CLEAR III: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT00784134
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH), Genentech, Inc. (Industry), Emissary International LLC (Industry)
500
81
2
78
6.2
0.1
Study Details
Study Description
Brief Summary
The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
Study Start Date
:
Jul 1, 2009
Actual Primary Completion Date
:
Jul 1, 2015
Actual Study Completion Date
:
Jan 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Alteplase administration of alteplase via the intraventricular catheter |
Drug: Alteplase
1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses
Other Names:
|
| Placebo Comparator: Saline Placebo 1 ml of normal saline administered via the intraventricular catheter |
Other: Normal saline
1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses
|
Outcome Measures
Primary Outcome Measures
- Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis [180 days]
Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis [180 days]
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis [180 days]
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3 [180 days]
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3 [30 days and 180 days]
Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Secondary Outcome Measures
- All Cause Mortality [180 days]
- Clot Removal (Amount of Residual Blood) [72 hours]
Change in blood volume measured between stability scan and end of treatment scan
- Intensity of Critical Care Management - Hospital Days [30 days]
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
- Intensity of Critical Care Management - ICU Days [30 days]
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
- Intensity of Critical Care Management - ICP Management [30 days]
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
- Intensity of Critical Care Management - Mechanical Ventilation [30 days]
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
- Intensity of Critical Care Management - Pressors [30 days]
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
- Intensity of Critical Care Management - Shunts [30 days]
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
- Intensity of Critical Care Management - All Infections [30 days]
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
- Intensity of Critical Care Management - Pneumonia [30 days]
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
- Intensity of Critical Care Management - All Infections [180 days]
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.
- Safety/Mortality - Mortality Within 30 Days [30 days]
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
- Safety/Mortality - Bacterial Brain Infections Within 30 Days [30 days]
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
- Safety/Mortality - Systematic Bleeds Within 72 Hours [72 hours]
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
- Safety/Mortality - Systematic Bleeds Within 30 Days [30 days]
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.
- Adverse and Serious Adverse Events [180 days]
Assessment of number of adverse and serious adverse events by treatment group.
- Predicting Hazards of Death by Treatment Group [180 days]
Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group.
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American) [180 days]
Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White) [180 days]
Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female) [180 days]
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male) [180 days]
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under) [180 days]
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years) [180 days]
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml) [180 days]
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml) [180 days]
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml) [180 days]
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic) [180 days]
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic) [180 days]
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
- Functional Status - Barthel Index [180 days]
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence.
- Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability [180 days]
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery.
- Functional Status - National Institutes of Health Stroke Scale (NIHSS) [180 days]
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke).
- Quality of Life - Stroke Impact Scale (SIS) - Strength [180 days]
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
- Quality of Life - Stroke Impact Scale (SIS) - Mobility [180 days]
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
- Quality of Life - Stroke Impact Scale (SIS) - Hand Function [180 days]
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
- Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living [180 days]
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
- Quality of Life - Stroke Impact Scale (SIS) - Communication [180 days]
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
- Quality of Life - Stroke Impact Scale (SIS) - Thinking [180 days]
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
- Quality of Life - Stroke Impact Scale (SIS) - Emotion [180 days]
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
- Quality of Life - Stroke Impact Scale (SIS) - Participation [180 days]
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
- Quality of Life - Stroke Impact Scale (SIS) - Recovery [180 days]
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.
- Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS) [180 days]
Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age 18-80
-
Symptom onset less than 24 hrs prior to diagnostic CT scan
-
Spontaneous ICH less than or equal to 30 cc or primary IVH
-
IVH obstructing 3rd and/or 4th ventricles
-
ICH clot stability at 6 hours or more post IVC placement
-
IVH clot stability at 6 hours or more post IVC placement
-
Catheter tract bleeding stability 6 hours or more post IVC placement
-
EVD placed per standard medical care
-
SBP less than 200 mmHg sustained for 6 hours prior to drug administration
-
Able to randomize within 72 hours of diagnostic CT scan
-
Historical Rankin of 0 or 1
Exclusion Criteria:
-
Suspected or untreated ruptured cerebral aneurysm, AVM, or tumor
-
Presence of a choroid plexus vascular malformation or Moyamoya
-
Clotting disorders
-
Platelet count less than 100,000, INR greater than 1.4
-
Pregnancy
-
Infratentorial hemorrhage
-
SAH at clinical presentation
-
ICH/IVH enlargement that cannot be stabilized in the treatment time window
-
Ongoing internal bleeding
-
Superficial or surface bleeding
-
Prior enrollment in the study
-
Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
-
Planned or simultaneous participation (between screening and Day-30) in another interventional medical investigation or clinical trial.
-
No subject or legal representative to give written informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | Mayo Clinic, Arizona | Phoenix | Arizona | United States | 85054 |
| 3 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 4 | University of Southern California - Keck School of Medicine | Los Angeles | California | United States | 90089 |
| 5 | University of California Los Angeles | Los Angeles | California | United States | 90095 |
| 6 | Stanford University | Palo Alto | California | United States | 94034 |
| 7 | Hartford Hospital | Hartford | Connecticut | United States | 06106 |
| 8 | Yale University | New Haven | Connecticut | United States | 06520-8018 |
| 9 | Georgetown University | Washington | District of Columbia | United States | 20007 |
| 10 | Mayo Clinic, Jacksonville | Jacksonville | Florida | United States | 32224 |
| 11 | Intercoastal Medical Center | Sarasota | Florida | United States | 34232 |
| 12 | University of South Florida | Tampa | Florida | United States | 33606 |
| 13 | Rush University | Chicago | Illinois | United States | 60612 |
| 14 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
| 15 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 16 | Ruan Neurology Clinical and Research Center | Des Moines | Iowa | United States | 50314 |
| 17 | University of Iowa | Iowa City | Iowa | United States | 52242 |
| 18 | Kansas University Medical Center | Kansas City | Kansas | United States | 66160 |
| 19 | University of Maryland | Baltimore | Maryland | United States | 21201 |
| 20 | Johns Hopkins University | Baltimore | Maryland | United States | 21230 |
| 21 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 22 | St. Luke's Brain and Stroke Institute | Kansas City | Missouri | United States | 64111 |
| 23 | St. Louis University | Saint Louis | Missouri | United States | 63104 |
| 24 | Springfield Neurological and Spine Institute | Springfield | Missouri | United States | 65804 |
| 25 | Cooper University Hospital | Camden | New Jersey | United States | 08103 |
| 26 | New Jersey Neuroscience Institute at JFK | Edison | New Jersey | United States | 08818 |
| 27 | University of Buffalo | Buffalo | New York | United States | 14203 |
| 28 | Northshore University Hospital Long Island | Manhasset | New York | United States | 11030 |
| 29 | Mount Sinai Hospital | New York | New York | United States | 10029 |
| 30 | Columbia University | New York | New York | United States | 10032 |
| 31 | SUNY Upstate Medical Center | Syracuse | New York | United States | 13210 |
| 32 | Wake Forest University | Winston-Salem | North Carolina | United States | 27157 |
| 33 | University of Cincinnati | Cincinnati | Ohio | United States | 45219 |
| 34 | Case-Western Reserve University Hospital | Cleveland | Ohio | United States | 44106 |
| 35 | Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
| 36 | Maine Medical Center | Portland | Oregon | United States | 04102 |
| 37 | Providence Stroke Center | Portland | Oregon | United States | 97225 |
| 38 | Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
| 39 | Penn State Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 40 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 41 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
| 42 | Albert Einstein Medical Center | Philadelphia | Pennsylvania | United States | 19141 |
| 43 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
| 44 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
| 45 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 46 | Vanderbilt | Nashville | Tennessee | United States | 37232 |
| 47 | University of Texas, Southwestern, Dallas | Dallas | Texas | United States | 75390 |
| 48 | University of Texas, Houston | Houston | Texas | United States | 77030 |
| 49 | University of Texas, San Antonio | San Antonio | Texas | United States | 78229 |
| 50 | University of Utah | Salt Lake City | Utah | United States | 84132 |
| 51 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
| 52 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 53 | Hospital Sao Jose, Joinville | Joinville | Santa Catarina | Brazil | 89202165 |
| 54 | Hospital de Clinicas de Porto Alegre | Porto Alegre | Brazil | 90035-903 | |
| 55 | Hospital de Pronto Socorro de Porto Alegre | Porto Alegre | Brazil | ||
| 56 | Hospital de Clinicas de Ribeirao Preto | Ribeirão Preto | Brazil | 14015-130 | |
| 57 | Hospital Sao Paulo Universidade Federal de Sao Paulo / UNIFESP | Sao Paulo | Brazil | 04039032 | |
| 58 | University of Alberta | Edmonton | Alberta | Canada | T6G 2B7 |
| 59 | Montreal Neurological Institute at McGill University | Montreal | Quebec | Canada | H3A 2B4 |
| 60 | University of Erlangen | Erlangen | Germany | 91054 | |
| 61 | University of Halle | Halle | Germany | D-06120 | |
| 62 | University of Heidelberg | Heidelberg | Germany | 69120 | |
| 63 | University of Leipzig | Leipzig | Germany | 04103 | |
| 64 | University of Mainz | Mainz | Germany | D-55131 | |
| 65 | University of Tubingen | Tübingen | Germany | 72076 | |
| 66 | University of Szeged | Szeged | Csongrad | Hungary | 6725 |
| 67 | Honved Korhaz | Budapest | Hungary | 1134 | |
| 68 | University of Debrecen | Debrecen | Hungary | 4032 | |
| 69 | University of Pecs | Pecs | Hungary | 7623 | |
| 70 | Rambam Medical Center | Haifa | Israel | 31096 | |
| 71 | Hadassah Hebrew University Hospital | Jerusalem | Israel | 91120 | |
| 72 | Chaim Sheba Medical Center | Ramat-Gan | Israel | 52621 | |
| 73 | Sourasky Medical Center | Tel Aviv | Israel | 64239 | |
| 74 | Bellvitge Hospital | Barcelona | Spain | 08015 | |
| 75 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | 08025 | |
| 76 | Vall d'Hebron University Hospital | Barcelona | Spain | 08035 | |
| 77 | University of Zurich | Zurich | ZH | Switzerland | CH-8091 |
| 78 | University Hospital, Inselpital, Bern | Bern | Switzerland | ||
| 79 | Salford Royal NHS Foundation Trust | Salford | Manchester | United Kingdom | M6 8HD |
| 80 | Newcastle General Hospital | Newcastle upon Tyne | United Kingdom | NE4 6BE | |
| 81 | University of Southampton Hospital | Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Johns Hopkins University
- National Institute of Neurological Disorders and Stroke (NINDS)
- Genentech, Inc.
- Emissary International LLC
Investigators
- Study Chair: Daniel F. Hanley, MD, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00784134
Other Study ID Numbers:
- IVH06
- 5U01NS062851-05
First Posted:
Nov 2, 2008
Last Update Posted:
Dec 5, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Period Title: Overall Study | ||
| STARTED | 249 | 251 |
| COMPLETED | 246 | 245 |
| NOT COMPLETED | 3 | 6 |
Baseline Characteristics
| Arm/Group Title | Alteplase | Saline Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses | Total of all reporting groups |
| Overall Participants | 249 | 251 | 500 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
182
73.1%
|
172
68.5%
|
354
70.8%
|
| >=65 years |
67
26.9%
|
79
31.5%
|
146
29.2%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
105
42.2%
|
117
46.6%
|
222
44.4%
|
| Male |
144
57.8%
|
134
53.4%
|
278
55.6%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
1
0.4%
|
1
0.2%
|
| Asian |
7
2.8%
|
7
2.8%
|
14
2.8%
|
| Native Hawaiian or Other Pacific Islander |
3
1.2%
|
1
0.4%
|
4
0.8%
|
| Black or African American |
92
36.9%
|
78
31.1%
|
170
34%
|
| White |
144
57.8%
|
161
64.1%
|
305
61%
|
| More than one race |
0
0%
|
1
0.4%
|
1
0.2%
|
| Unknown or Not Reported |
3
1.2%
|
2
0.8%
|
5
1%
|
| Region of Enrollment (participants) [Number] | |||
| Canada |
3
1.2%
|
6
2.4%
|
9
1.8%
|
| Hungary |
7
2.8%
|
6
2.4%
|
13
2.6%
|
| United States |
190
76.3%
|
180
71.7%
|
370
74%
|
| Brazil |
1
0.4%
|
3
1.2%
|
4
0.8%
|
| United Kingdom |
4
1.6%
|
4
1.6%
|
8
1.6%
|
| Israel |
13
5.2%
|
24
9.6%
|
37
7.4%
|
| Switzerland |
1
0.4%
|
3
1.2%
|
4
0.8%
|
| Germany |
21
8.4%
|
18
7.2%
|
39
7.8%
|
| Spain |
9
3.6%
|
7
2.8%
|
16
3.2%
|
Outcome Measures
| Title | Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis |
|---|---|
| Description | Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing mRS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 246 | 245 |
| Number [percentage of participants] |
47.6
19.1%
|
44.9
17.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.554 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.027 | |
| Confidence Interval |
(2-Sided) 95% -0.062 to 0.115 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.465 |
| Comments | Multivariable logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume. | |
| Method | Multivariable Logit Model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.18 | |
| Confidence Interval |
(2-Sided) 95% 0.75 to 1.87 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis |
|---|---|
| Description | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing mRS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 246 | 245 |
| Median (Inter-Quartile Range) [mRS score] |
4
|
4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.484 |
| Comments | Generalized ordered logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical) compares odds ratio for mRS score > K v. <= K for K = 1 - 4; Alt v. Sal. | |
| Method | Generalized ordered Logit Model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.89 | |
| Confidence Interval |
(2-Sided) 95% 0.63 to 1.25 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | The same generalized ordered logit model, adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical), compares odds ratio for mRS score greater than 5 versus mRS score equal or less than 5 (dead versus alive). | |
| Method | Generalized ordered Logit Model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.44 | |
| Confidence Interval |
(2-Sided) 95% 0.28 to 0.71 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis |
|---|---|
| Description | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing mRS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 246 | 245 |
| Number [percentage of participants] |
64.2
25.8%
|
61.6
24.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.552 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.026 | |
| Confidence Interval |
(2-Sided) 95% -0.059 to 0.111 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.350 |
| Comments | Multivariable logit model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical). | |
| Method | Multivariable Logit Model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.23 | |
| Confidence Interval |
(2-Sided) 95% 0.80 to 1.90 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3 |
|---|---|
| Description | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing mRS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 246 | 245 |
| Number [percentage of participants] |
47.6
19.1%
|
44.9
17.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.428 |
| Comments | Random effects model with site as random effect adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical). | |
| Method | Random Effects Model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.18 | |
| Confidence Interval |
(2-Sided) 95% 0.78 to 1.80 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3 |
|---|---|
| Description | Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 30 days and 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing mRS scores at 30 days and 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 246 | 249 |
| Day 30 |
20.4
8.2%
|
16.5
6.6%
|
| Day 180 |
48.0
19.3%
|
45.7
18.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | Logit mRS scores 0-3 at 30 days | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.384 |
| Comments | ||
| Method | Generalized Estimating Equation Model | |
| Comments | Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical). | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.26 | |
| Confidence Interval |
(2-Sided) 95% 0.75 to 2.10 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | Logit mRS scores 0-3 at 180 days | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.964 |
| Comments | ||
| Method | Generalized Estimating Equation Model | |
| Comments | Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical). | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.01 | |
| Confidence Interval |
(2-Sided) 95% 0.62 to 1.64 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | All Cause Mortality |
|---|---|
| Description | |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [percentage of participants] |
18.5
7.4%
|
29.1
11.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0056 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Clot Removal (Amount of Residual Blood) |
|---|---|
| Description | Change in blood volume measured between stability scan and end of treatment scan |
| Time Frame | 72 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [odds ratio per time-weighted ml] |
0.96
|
0.97
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | AUC/ Logit Model | |
| Comments | ||
| Title | Intensity of Critical Care Management - Hospital Days |
|---|---|
| Description | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Median (Inter-Quartile Range) [Number of days] |
23
|
24
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.771 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
| Title | Intensity of Critical Care Management - ICU Days |
|---|---|
| Description | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Median (Inter-Quartile Range) [Number of days] |
14
|
15
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.098 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
| Title | Intensity of Critical Care Management - ICP Management |
|---|---|
| Description | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [Percentage of events of ICP >20mmHg] |
9.8
|
10.2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.450 |
| Comments | ||
| Method | Generalized Linear Models | |
| Comments | ||
| Title | Intensity of Critical Care Management - Mechanical Ventilation |
|---|---|
| Description | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [% of participants with ventilation] |
73.9
29.7%
|
76.5
30.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.501 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Intensity of Critical Care Management - Pressors |
|---|---|
| Description | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [% of participants with pressors] |
24.1
9.7%
|
25.1
10%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.795 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Intensity of Critical Care Management - Shunts |
|---|---|
| Description | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [% of participants with shunts] |
18.5
7.4%
|
17.5
7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.784 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Intensity of Critical Care Management - All Infections |
|---|---|
| Description | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [% of participants with infections] |
48.2
19.4%
|
50.6
20.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.592 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Intensity of Critical Care Management - Pneumonia |
|---|---|
| Description | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [% of participants with pneumonia] |
26.1
10.5%
|
32.7
13%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.105 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Intensity of Critical Care Management - All Infections |
|---|---|
| Description | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [% of participants with infections] |
49.8
20%
|
56.2
22.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.152 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Safety/Mortality - Mortality Within 30 Days |
|---|---|
| Description | Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [Percentage of patients] |
8.8
|
14.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.055 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | -0.055 | |
| Confidence Interval |
(2-Sided) 95% -0.111 to 0.008 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Safety/Mortality - Bacterial Brain Infections Within 30 Days |
|---|---|
| Description | Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [% of participants with brain infection] |
6.8
2.7%
|
10.4
4.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.202 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | -0.035 | |
| Confidence Interval |
(2-Sided) 95% -0.084 to 0.014 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Safety/Mortality - Systematic Bleeds Within 72 Hours |
|---|---|
| Description | Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. |
| Time Frame | 72 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [% of participants with systematic bleeds] |
2.4
1%
|
2.0
0.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.771 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.004 | |
| Confidence Interval |
(2-Sided) 95% -0.022 to 0.030 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Safety/Mortality - Systematic Bleeds Within 30 Days |
|---|---|
| Description | Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [% of participants with systematic bleeds] |
3.6
1.4%
|
3.2
1.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.811 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.004 | |
| Confidence Interval |
(2-Sided) 95% -0.028 to 0.036 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Adverse and Serious Adverse Events |
|---|---|
| Description | Assessment of number of adverse and serious adverse events by treatment group. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [percentage of participants] |
45.8
18.4%
|
60.2
24%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0017 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | -0.144 | |
| Confidence Interval |
(2-Sided) 95% -0.230 to -0.057 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Predicting Hazards of Death by Treatment Group |
|---|---|
| Description | Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that were enrolled in CLEAR III were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 249 | 251 |
| Number [percentage of participants] |
18.5
7.4%
|
29.1
11.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | ||
| Method | Cox Proportional Hazards Model | |
| Comments | Adjusted Cox Proportional Hazards Model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical). | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.60 | |
| Confidence Interval |
(2-Sided) 95% 0.41 to 0.86 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American) |
|---|---|
| Description | Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that reported they were African-American with a non-missing mRS score at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 90 | 75 |
| Number [Percentage of participants] |
54.4
21.8%
|
48.0
19.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.410 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.064 | |
| Confidence Interval |
(2-Sided) 95% -0.088 to 0.217 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White) |
|---|---|
| Description | Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that reported they were White with a non-missing mRS score at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 143 | 158 |
| Number [percentage of participants] |
43.4
17.4%
|
41.8
16.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.781 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.016 | |
| Confidence Interval |
(2-Sided) 95% -0.096 to 0.128 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female) |
|---|---|
| Description | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All female patients with a non-missing mRS score at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 103 | 114 |
| Number [percentage of participants] |
47.6
19.1%
|
45.6
18.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.773 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.020 | |
| Confidence Interval |
(2-Sided) 95% -0.113 to 0.152 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male) |
|---|---|
| Description | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All male patients with a non-missing mRS score at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 143 | 131 |
| Number [percentage of participants] |
47.6
19.1%
|
44.3
17.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.587 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.032 | |
| Confidence Interval |
(2-Sided) 95% -0.085 to 0.151 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under) |
|---|---|
| Description | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients 65 years of age or under with a non-missing mRS score at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 179 | 167 |
| Number [Percentage of participants] |
53.6
21.5%
|
52.1
20.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.775 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.015 | |
| Confidence Interval |
(2-Sided) 95% -0.09 to 0.121 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years) |
|---|---|
| Description | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients over 65 years of age with a non-missing mRS score at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 67 | 78 |
| Number [Percentage of participants] |
31.3
12.6%
|
29.5
11.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.808 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.019 | |
| Confidence Interval |
(2-Sided) 95% -0.132 to 0.169 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml) |
|---|---|
| Description | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with an IVH size less than 20ml and a non-missing mRS score at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 109 | 108 |
| Number [percentage of participants] |
55.1
22.1%
|
58.3
23.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.625 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.033 | |
| Confidence Interval |
(2-Sided) 95% -0.165 to 0.099 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml) |
|---|---|
| Description | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with an IVH size between 20ml and 50ml and a non-missing mRS score at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 110 | 109 |
| Number [percentage of participants] |
47.3
19%
|
38.5
15.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.191 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.087 | |
| Confidence Interval |
(2-Sided) 95% -0.043 to 0.218 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml) |
|---|---|
| Description | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with an IVH size greater than 50ml and a non-missing mRS score at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 27 | 28 |
| Number [percentage of participants] |
18.5
7.4%
|
17.9
7.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.949 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.0066 | |
| Confidence Interval |
(2-Sided) 95% -0.197 to 0.211 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic) |
|---|---|
| Description | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with a thalamic blood clot location and a non-missing mRS score at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 147 | 139 |
| Number [percentage of participants] |
38.8
15.6%
|
37.4
14.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.812 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.014 | |
| Confidence Interval |
(2-Sided) 95% -0.098 to 0.126 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic) |
|---|---|
| Description | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with a non-thalamic blood clot location and a non-missing mRS score at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 99 | 106 |
| Number [percentage of participants] |
60.6
24.3%
|
54.7
21.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.394 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.059 | |
| Confidence Interval |
(2-Sided) 95% -0.076 to 0.194 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Functional Status - Barthel Index |
|---|---|
| Description | Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing Barthel scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 197 | 170 |
| Mean (Standard Deviation) [Barthel score] |
65.2
(37.7)
|
69.5
(35.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.312 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability |
|---|---|
| Description | Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing eGOS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 241 | 241 |
| Number [% of participants with score>=4] |
95
38.2%
|
77
30.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.087 |
| Comments | Analysis of dichotomous eGOS, comparing Upper Severe Disability scores to Lower Severe Disability scores | |
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.075 | |
| Confidence Interval |
(2-Sided) 95% -0.011 to 0.160 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.064 |
| Comments | Adjusted Multivariable Logit Model comparing eGOS scores of Upper Severe Disability or greater versus Lower Severe Disability and worse; Alteplase versus Saline | |
| Method | Multivariable Logit Model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.54 | |
| Confidence Interval |
(2-Sided) 95% 0.98 to 2.43 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.336 |
| Comments | Adjusted generalized ordered logit model odds ratios for eGOS scores of Moderate Disability or worse versus Good Recovery; Alteplase versus Saline | |
| Method | Generalized Ordered Logit Model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.42 | |
| Confidence Interval |
(2-Sided) 95% 0.70 to 2.89 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.783 |
| Comments | Adjusted generalized ordered logit model odds ratios for eGOS scores of Upper Severe Disability or worse versus Moderate Disability + Good Recovery; Alteplase versus Saline | |
| Method | Generalized Ordered Logit Model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.93 | |
| Confidence Interval |
(2-Sided) 95% 0.57 to 1.52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Functional Status - National Institutes of Health Stroke Scale (NIHSS) |
|---|---|
| Description | Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing NIHSS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 182 | 158 |
| Median (Inter-Quartile Range) [NIHSS score] |
3
|
2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Quality of Life - Stroke Impact Scale (SIS) - Strength |
|---|---|
| Description | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing SIS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 186 | 165 |
| Mean (Standard Deviation) [SIS score] |
54.97
(35.37)
|
58.75
(34.36)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.312 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Quality of Life - Stroke Impact Scale (SIS) - Mobility |
|---|---|
| Description | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing SIS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 186 | 165 |
| Mean (Standard Deviation) [SIS score] |
58.30
(38.16)
|
60.10
(36.05)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.65 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Quality of Life - Stroke Impact Scale (SIS) - Hand Function |
|---|---|
| Description | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing SIS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 186 | 165 |
| Mean (Standard Deviation) [SIS score] |
53.41
(41.86)
|
56.52
(39.69)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.478 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living |
|---|---|
| Description | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing SIS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 186 | 165 |
| Mean (Standard Deviation) [SIS score] |
59.33
(37.90)
|
61.19
(34.98)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.634 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Quality of Life - Stroke Impact Scale (SIS) - Communication |
|---|---|
| Description | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing SIS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 185 | 165 |
| Mean (Standard Deviation) [SIS score] |
76.02
(31.47)
|
79.60
(26.76)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.255 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Quality of Life - Stroke Impact Scale (SIS) - Thinking |
|---|---|
| Description | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing SIS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 185 | 165 |
| Mean (Standard Deviation) [SIS score] |
58.48
(33.11)
|
62.68
(31.18)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.224 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Quality of Life - Stroke Impact Scale (SIS) - Emotion |
|---|---|
| Description | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing SIS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 185 | 163 |
| Mean (Standard Deviation) [SIS score] |
73.14
(19.62)
|
73.45
(20.24)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.882 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Quality of Life - Stroke Impact Scale (SIS) - Participation |
|---|---|
| Description | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing SIS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 186 | 163 |
| Mean (Standard Deviation) [SIS score] |
47.46
(33.01)
|
49.58
(33.03)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.551 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Quality of Life - Stroke Impact Scale (SIS) - Recovery |
|---|---|
| Description | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing SIS scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 185 | 162 |
| Mean (Standard Deviation) [SIS score] |
60.04
(26.42)
|
63.44
(25.44)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.224 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS) |
|---|---|
| Description | Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine). |
| Time Frame | 180 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All the non-missing EuroQol scores at 180 days were analyzed. |
| Arm/Group Title | Alteplase | Saline Placebo |
|---|---|---|
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
| Measure Participants | 177 | 160 |
| Mean (Standard Deviation) [EuroQol score] |
62.8
(26.0)
|
65.1
(23.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Alteplase, Saline Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.376 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Adverse Events
| Time Frame | 180 days since symptom onset | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Alteplase | Saline Placebo | ||
| Arm/Group Description | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses | ||
All Cause Mortality |
||||
| Alteplase | Saline Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Alteplase | Saline Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 114/249 (45.8%) | 151/251 (60.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 2/249 (0.8%) | 2 | 2/251 (0.8%) | 2 |
| Thrombocytopenia | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Cardiac disorders | ||||
| Acute coronary syndrome | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Asystole | 2/249 (0.8%) | 2 | 2/251 (0.8%) | 2 |
| Atrial fibrillation | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Cardiac arrest | 5/249 (2%) | 5 | 9/251 (3.6%) | 9 |
| Congestive heart failure | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Heart failure | 0/249 (0%) | 0 | 2/251 (0.8%) | 2 |
| Intercardiac clot | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Myocardial infarction | 0/249 (0%) | 0 | 3/251 (1.2%) | 3 |
| Myocarditis | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Sinus bradycardia | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Sinus tachycardia | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Supraventricular tachydysrhythmia | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Takotsubo syndrome | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Ventricular fibrillation | 1/249 (0.4%) | 1 | 1/251 (0.4%) | 1 |
| Gastrointestinal disorders | ||||
| Colitis | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Colonic perforation | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Duodenal hemorrhage | 2/249 (0.8%) | 3 | 0/251 (0%) | 0 |
| Enterocolitis | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Esophageal hemorrhage | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Gastric hemorrhage | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Gastrointestinal pain | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Gastroparesis | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Lower gastrointestinal hemorrhage | 2/249 (0.8%) | 2 | 0/251 (0%) | 0 |
| Swollen tongue | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Vomiting | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| General disorders | ||||
| Cerebrovascular death (brain death) | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Death due to index bleeding event | 10/249 (4%) | 10 | 21/251 (8.4%) | 21 |
| Fever | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Multi-organ failure | 1/249 (0.4%) | 1 | 3/251 (1.2%) | 3 |
| Sudden death NOS | 6/249 (2.4%) | 6 | 8/251 (3.2%) | 8 |
| Hepatobiliary disorders | ||||
| Hepatic failure | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Hepatorenal syndrome | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Intrahepatic cholestasis of unk etiology | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Immune system disorders | ||||
| Allergic reaction | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Infections and infestations | ||||
| Abdominal infection | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Bacteremia | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Bronchial infection | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Peritoneal infection | 0/249 (0%) | 0 | 2/251 (0.8%) | 2 |
| Sepsis | 11/249 (4.4%) | 13 | 7/251 (2.8%) | 8 |
| Tracheitis | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Urinary tract infection | 3/249 (1.2%) | 3 | 8/251 (3.2%) | 9 |
| Ventriculitis, bacterial | 1/249 (0.4%) | 1 | 1/251 (0.4%) | 1 |
| Ventriculitis, non-bacterial | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Wound infection, non-neurologic | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Fracture | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Pulmonary embolism | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Tracheostomy site bleeding | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Investigations | ||||
| INR increased | 0/249 (0%) | 0 | 4/251 (1.6%) | 4 |
| Platelet count decreased | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Diabetes mellitus, Type I | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Hypernatremia | 2/249 (0.8%) | 2 | 0/251 (0%) | 0 |
| Hypoglycemia | 2/249 (0.8%) | 2 | 0/251 (0%) | 0 |
| Hyponatremia | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Chest wall pain | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Muscle weakness left-sided | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Nervous system disorders | ||||
| Altered mental status | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Anoxic brain damage | 1/249 (0.4%) | 1 | 1/251 (0.4%) | 1 |
| Anoxic brain injury | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Aphasia | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Brain and catheter related infection | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Brainstorming/autonomic dysfunction | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Cerebrospinal fluid leakage | 0/249 (0%) | 0 | 3/251 (1.2%) | 3 |
| Cerebrovascular death (brain death) | 2/249 (0.8%) | 2 | 6/251 (2.4%) | 6 |
| Cognitive disturbance | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Death due to index bleeding event | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Depressed level of consciousness | 7/249 (2.8%) | 7 | 3/251 (1.2%) | 3 |
| Diencephalic storming | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Edema cerebral | 3/249 (1.2%) | 3 | 2/251 (0.8%) | 2 |
| Encephalopathy | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Extensor posturing | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Herniation | 1/249 (0.4%) | 1 | 2/251 (0.8%) | 2 |
| Hydrocephalus | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Hydrocephalus, communicating | 14/249 (5.6%) | 14 | 13/251 (5.2%) | 13 |
| Hydrocephalus, obstructive | 1/249 (0.4%) | 1 | 3/251 (1.2%) | 3 |
| Intracranial abcess | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Intracranial hemorrhage: Catheter Tract, Enlargement | 2/249 (0.8%) | 2 | 1/251 (0.4%) | 1 |
| Intracranial hemorrhage: Catheter Tract, New | 8/249 (3.2%) | 9 | 7/251 (2.8%) | 7 |
| Intracranial hemorrhage: Hematoma, subdural | 1/249 (0.4%) | 2 | 2/251 (0.8%) | 2 |
| Intracranial hemorrhage: Subarachnoid Space, New | 1/249 (0.4%) | 1 | 1/251 (0.4%) | 1 |
| Intracranial hemorrhage: Tissue, Enlargement | 1/249 (0.4%) | 1 | 1/251 (0.4%) | 1 |
| Intracranial hemorrhage: Tissue, New | 2/249 (0.8%) | 2 | 5/251 (2%) | 5 |
| Intracranial hemorrhage: Ventricular system, Enlargement | 3/249 (1.2%) | 3 | 2/251 (0.8%) | 2 |
| Intracranial hemorrhage: Ventricular system, New | 2/249 (0.8%) | 2 | 3/251 (1.2%) | 3 |
| Intracranial hypertension | 9/249 (3.6%) | 9 | 8/251 (3.2%) | 11 |
| Ischemia cerebrovascular | 3/249 (1.2%) | 3 | 0/251 (0%) | 0 |
| Meningitis | 2/249 (0.8%) | 2 | 3/251 (1.2%) | 3 |
| Reversible cerebral vasoconstriction vs vasculitis | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Seizure | 3/249 (1.2%) | 3 | 1/251 (0.4%) | 1 |
| Stroke | 4/249 (1.6%) | 4 | 4/251 (1.6%) | 4 |
| VP shunt dysfunction | 1/249 (0.4%) | 1 | 1/251 (0.4%) | 1 |
| Vasospasm or DIND | 2/249 (0.8%) | 2 | 0/251 (0%) | 0 |
| Ventriculitis, bacterial | 3/249 (1.2%) | 3 | 10/251 (4%) | 12 |
| Ventriculitis, non-bacterial | 4/249 (1.6%) | 4 | 3/251 (1.2%) | 3 |
| Psychiatric disorders | ||||
| Delirium | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Depression | 1/249 (0.4%) | 3 | 0/251 (0%) | 0 |
| Personality change | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Renal and urinary disorders | ||||
| Acute renal failure | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Chronic kidney disease | 2/249 (0.8%) | 2 | 0/251 (0%) | 0 |
| Interstitial nephritis | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Renal calculi | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Renal insufficiency | 6/249 (2.4%) | 6 | 6/251 (2.4%) | 6 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Adult respiratory distress syndrome | 3/249 (1.2%) | 3 | 4/251 (1.6%) | 4 |
| Aspiration | 2/249 (0.8%) | 2 | 6/251 (2.4%) | 6 |
| Atelectasis | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| COPD | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Epistaxis | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Hypoxia | 1/249 (0.4%) | 1 | 2/251 (0.8%) | 2 |
| Laryngeal edema | 1/249 (0.4%) | 1 | 2/251 (0.8%) | 2 |
| Pneumonia | 17/249 (6.8%) | 19 | 13/251 (5.2%) | 14 |
| Pulmonary edema | 1/249 (0.4%) | 1 | 2/251 (0.8%) | 2 |
| Pulmonary embolism | 7/249 (2.8%) | 7 | 4/251 (1.6%) | 4 |
| Pulmonary hypertension | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Respiratory failure | 12/249 (4.8%) | 12 | 17/251 (6.8%) | 17 |
| Stridor | 4/249 (1.6%) | 4 | 1/251 (0.4%) | 1 |
| Tachypnea | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Tracheal mucositis | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Rash acneiform | 0/249 (0%) | 0 | 1/251 (0.4%) | 1 |
| Surgical and medical procedures | ||||
| PEG Tube complication | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Vascular disorders | ||||
| Deep vein thrombosis | 6/249 (2.4%) | 6 | 5/251 (2%) | 5 |
| Hypertension | 1/249 (0.4%) | 1 | 0/251 (0%) | 0 |
| Hypotension | 1/249 (0.4%) | 1 | 1/251 (0.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Alteplase | Saline Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 165/249 (66.3%) | 178/251 (70.9%) | ||
| General disorders | ||||
| Fever | 72/249 (28.9%) | 76 | 67/251 (26.7%) | 74 |
| Infections and infestations | ||||
| Bacteremia | 13/249 (5.2%) | 13 | 6/251 (2.4%) | 7 |
| Urinary tract infection | 36/249 (14.5%) | 38 | 23/251 (9.2%) | 23 |
| Nervous system disorders | ||||
| Depressed level of consciousness | 6/249 (2.4%) | 7 | 12/251 (4.8%) | 13 |
| Hydrocephalus, communicating | 24/249 (9.6%) | 24 | 33/251 (13.1%) | 33 |
| Intracranial hemorrhage: Catheter Tract, New | 34/249 (13.7%) | 37 | 39/251 (15.5%) | 47 |
| Intracranial hypertension | 39/249 (15.7%) | 53 | 42/251 (16.7%) | 50 |
| Seizure | 13/249 (5.2%) | 14 | 16/251 (6.4%) | 20 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pneumonia | 41/249 (16.5%) | 41 | 53/251 (21.1%) | 53 |
| Vascular disorders | ||||
| Deep vein thrombosis | 21/249 (8.4%) | 21 | 20/251 (8%) | 20 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Daniel F. Hanley |
|---|---|
| Organization | Johns Hopkins University Division of Brain Injury Outcomes |
| Phone | 4106146996 |
| dhanley@jhmi.edu |
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00784134
Other Study ID Numbers:
- IVH06
- 5U01NS062851-05
First Posted:
Nov 2, 2008
Last Update Posted:
Dec 5, 2018
Last Verified:
Nov 1, 2018