OPTIMIST: Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02039375
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Actual Duration (Months): 52
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Intravenous (IV) tissue plasminogen activator (tPA) is the only FDA-approved therapy for treatment of acute ischemic stroke. In the United States, IV tPA is typically administered in the Emergency Department (ED) for patients presenting with acute ischemic stroke within 4.5 hours of symptom onset. It is current practice that post-tPA patients are monitored in an intensive care unit or intensive care unit (ICU)-like setting for at least 24 hours, in part due to frequent vital sign and neurological monitoring that is currently the standard of care. However, rigorous evidence to support this practice is largely lacking. In a retrospective analysis of 153 patients receiving IV tPA at Johns Hopkins Hospital (JHH) and Johns Hopkins Bayview Medical Center (JHBMC), investigators have shown that most patients who have ICU needs in the first 24 hours after tPA administration develop such needs by the end of the tPA infusion. Patients without ICU needs by the end of the tPA infusion, do not require further ICU resources if patients' presenting NIH Stroke Scale (NIHSS) is below 10. This study is a prospective clinical trial that aims at establishing the first proof-of-concept and feasibility of whether patients with a low NIHSS (NIHSS 9 or less) and that do not need ICU care by the end of the tPA infusion, can be monitored safely in a non-ICU setting with a novel monitoring protocol. Identifying post-tPA patients who can be safely monitored in a non-ICU environment may improve cost-effective utilization of ICU resources and reduce the length of hospitalization for stroke patients.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Ischemic Stroke	Other: "Hopkins" post tPA for ischemic stroke monitoring protocol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single arm studySingle arm study
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Optimal Post Tpa-Iv Monitoring in Ischemic STroke
• Actual Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Mar 21, 2018
• Actual Study Completion Date: Jun 30, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: "Hopkins" post tPA monitoring protocol Patients treated with IV tPA (intravenous tissue Plasminogen Activator) for acute stroke will be monitored in a non-ICU setting following the "Hopkins" post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA.

Other: "Hopkins" post tPA for ischemic stroke monitoring protocol; The "Hopkins" post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration [24 hours]

Secondary Outcome Measures

1. Severity of Stroke at 24 Hours as Assessed by the National Institutes of Health Stroke Scale (NIHSS) [24 hours]

   The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke.

2. Degree of Disability as Assessed by the Modified Rankin Score (mRS) [At the time of discharge from the hospital, up to 90 days]

   The mRS is a scale of disability with a score range from 0-6. 0 - no symptoms, back to normal. - some symptoms, able to do all prior activities, does not need help from others. - some symptoms, unable to do all prior activities, does not need help from others. - needs help from others, able to walk. - needs help from other, unable to walk without help. - needs total care. - the patient has expired.

3. Severity of Symptoms of Stroke at 90 Days as Assessed by the NIHSS [At 90 days]

   The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke.

4. Degree of Disability at 90 Days as Assessed by the mRS [At 90 days]

   The mRS is a scale of disability with a score range from 0-6. 0-no symptoms, back to normal. some symptoms, able to do all prior activities, does not need help from others. some symptoms, unable to do all prior activities, does not need help from others. needs help from others, able to walk. needs help from other, unable to walk without help. needs total care. the patient has expired.

5. Mortality at 90 Days [90 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ability to provide written informed consent (or a Legally Authorized Representative (LAR) available to provide informed consent) and comply with study assessments for the full duration of the study.

• Age 18-80 years

• Patients to be included will be diagnosed as having an acute ischemic stroke by history and physical exam and receive IV tPA within 4.5 hours of symptom onset according to current guidelines for acute stroke care.

• NIHSS at presentation <10

• Patients do not have ICU needs in the judgment of the treating ED physician or neurologist by the end of the tPA infusion

• NIHSS at the end of tPA infusion <10

Exclusion Criteria:

• For patients receiving IV tPA according to the current standard of care, the following exclusion criteria apply:

• Age <17 or >80

• ICU need or indication by the end of the tPA infusion

• NIHSS >9 at presentation or at the end of the tPA infusion

• Indication/need for endovascular recanalization therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Johns Hopkins Hospital	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Victor C Urrutia, MD, Johns Hopkins University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 18, 2013

More Information

Additional Information:

• Preliminary work
• Results paper

Publications

• Faigle R, Sharrief A, Marsh EB, Llinas RH, Urrutia VC. Predictors of critical care needs after IV thrombolysis for acute ischemic stroke. PLoS One. 2014 Feb 12;9(2):e88652. doi: 10.1371/journal.pone.0088652. eCollection 2014.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02039375
• Other Study ID Numbers: NA_00087038
• First Posted: Jan 17, 2014
• Last Update Posted: Mar 23, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Johns Hopkins University: IV tPA; Thrombolysis; Stroke; Ischemic; Monitoring
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia

Study Results

Participant Flow

Arm/Group Title	"Hopkins" Post tPA Monitoring Protocol
Arm/Group Description	Patients treated with IV tissue plasminogen activator (tPA) for acute stroke will be monitored in a non-ICU setting following the "Hopkins" post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA. "Hopkins" post tPA for ischemic stroke monitoring protocol: The "Hopkins" post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours.
Period Title: Overall Study
STARTED	35
COMPLETED	33
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	"Hopkins" Post tPA Monitoring Protocol
Arm/Group Description	Patients treated with IV tPA for acute stroke will be monitored in a non-ICU setting following the "Hopkins" post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA. "Hopkins" post tPA for ischemic stroke monitoring protocol: The "Hopkins" post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours.
Overall Participants	35
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	54
Sex: Female, Male (Count of Participants)
Female	14 40%
Male	21 60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	22 62.9%
White	13 37.1%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	35 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	"Hopkins" Post tPA Monitoring Protocol
Arm/Group Description	Patients treated with IV tPA for acute stroke will be monitored in a non-ICU setting following the "Hopkins" post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA. "Hopkins" post tPA for ischemic stroke monitoring protocol: The "Hopkins" post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours.
Measure Participants	35
Count of Participants [Participants]	0 0%

2. Secondary Outcome

Title	Severity of Stroke at 24 Hours as Assessed by the National Institutes of Health Stroke Scale (NIHSS)
Description	The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	"Hopkins" Post tPA Monitoring Protocol
Arm/Group Description	Patients treated with IV tPA for acute stroke will be monitored in a non-ICU setting following the "Hopkins" post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA. "Hopkins" post tPA for ischemic stroke monitoring protocol: The "Hopkins" post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours.
Measure Participants	35
Median (Inter-Quartile Range) [score on a scale]	1

3. Secondary Outcome

Title	Degree of Disability as Assessed by the Modified Rankin Score (mRS)
Description	The mRS is a scale of disability with a score range from 0-6. 0 - no symptoms, back to normal. - some symptoms, able to do all prior activities, does not need help from others. - some symptoms, unable to do all prior activities, does not need help from others. - needs help from others, able to walk. - needs help from other, unable to walk without help. - needs total care. - the patient has expired.
Time Frame	At the time of discharge from the hospital, up to 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	"Hopkins" Post tPA Monitoring Protocol
Arm/Group Description	Patients treated with IV tPA for acute stroke will be monitored in a non-ICU setting following the "Hopkins" post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA. "Hopkins" post tPA for ischemic stroke monitoring protocol: The "Hopkins" post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours.
Measure Participants	35
Median (Full Range) [score on a scale]	1

4. Secondary Outcome

Title	Severity of Symptoms of Stroke at 90 Days as Assessed by the NIHSS
Description	The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke.
Time Frame	At 90 days

Outcome Measure Data

Analysis Population Description

The NIHSS assessment at 90 days was not done for 7 participants.

Arm/Group Title	"Hopkins" Post tPA Monitoring Protocol
Arm/Group Description	Patients treated with IV tPA for acute stroke will be monitored in a non-ICU setting following the "Hopkins" post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA. "Hopkins" post tPA for ischemic stroke monitoring protocol: The "Hopkins" post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours.
Measure Participants	28
Median (Inter-Quartile Range) [score on a scale]	0

5. Secondary Outcome

Title	Degree of Disability at 90 Days as Assessed by the mRS
Description	The mRS is a scale of disability with a score range from 0-6. 0-no symptoms, back to normal. some symptoms, able to do all prior activities, does not need help from others. some symptoms, unable to do all prior activities, does not need help from others. needs help from others, able to walk. needs help from other, unable to walk without help. needs total care. the patient has expired.
Time Frame	At 90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	"Hopkins" Post tPA Monitoring Protocol
Arm/Group Description	Patients treated with IV tPA for acute stroke will be monitored in a non-ICU setting following the "Hopkins" post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA. "Hopkins" post tPA for ischemic stroke monitoring protocol: The "Hopkins" post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours.
Measure Participants	33
Median (Full Range) [score on a scale]	0

6. Secondary Outcome

Title	Mortality at 90 Days
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	"Hopkins" Post tPA Monitoring Protocol
Arm/Group Description	Patients treated with IV tPA for acute stroke will be monitored in a non-ICU setting following the "Hopkins" post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA. "Hopkins" post tPA for ischemic stroke monitoring protocol: The "Hopkins" post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours.
Measure Participants	35
Count of Participants [Participants]	1 2.9%

Adverse Events

Time Frame	90 days
Arm/Group Title	"Hopkins" Post tPA Monitoring Protocol
Arm/Group Description	Patients treated with IV tPA for acute stroke will be monitored in a non-ICU setting following the "Hopkins" post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA. "Hopkins" post tPA for ischemic stroke monitoring protocol: The "Hopkins" post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours.
All Cause Mortality
	"Hopkins" Post tPA Monitoring Protocol
	Affected / at Risk (%)	# Events
Total	1/35 (2.9%)
Serious Adverse Events
	"Hopkins" Post tPA Monitoring Protocol
	Affected / at Risk (%)	# Events
Total	1/35 (2.9%)
Cardiac disorders
Mortality	1/35 (2.9%)	1
Other (Not Including Serious) Adverse Events
	"Hopkins" Post tPA Monitoring Protocol
	Affected / at Risk (%)	# Events
Total	0/35 (0%)

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.