Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding
Sponsor
Baxter Healthcare Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02640235
Collaborator
(none)
260
25
2
19.8
10.4
0.5
Study Details
Study Description
Brief Summary
The study is to evaluate the effectiveness and safety of CELSTAT vs active control.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
260 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness and Safety of CELSTAT as an Adjunct to Hemostasis for Tissue Bleeding in Cardiothoracic, General, and Vascular Surgery.
Actual Study Start Date
:
Feb 24, 2016
Actual Primary Completion Date
:
Jul 21, 2017
Actual Study Completion Date
:
Oct 18, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CELSTAT Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site |
Device: CELSTAT
|
| Active Comparator: Surgicel Original Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site |
Device: Surgicel Original
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application [5 minute (post-application)]
Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding.
- Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration [Day 1 to Day 91]
Findings are reported in this outcome measure and would have also been reported as an AE.
Secondary Outcome Measures
- Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants [0 to 10 minutes (post-application)]
Data presented is an interpretation of a Kaplan-Meier plot based on quartiles of the survival distribution estimate. "Survival" times need not relate to actual survival with death being the event; the "event" may be any event of interest. The Kaplan-Meier curves and estimates of survival data have become a familiar way of dealing with differing survival times (times-to-event).
- Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application [3 minutes (post application)]
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
- Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application [7 minutes (post application)]
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
- Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application [10 minutes (post application)]
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
- Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis [0 to 10 minutes (post-application)]
If intraoperative re-bleeding occurred, the primary endpoint was considered "treatment failure."
- Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious) [Day 1 to Day 91]
Adverse Events (AEs) that occurred after the start of study treatment application are referred to as "treatment-emergent AEs" (TEAE). Timeframe for tracking AE's up to Day 91 (minus/plus 10 days=from Day 81 to Day 101).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Preoperative
- Subject is undergoing planned cardiothoracic, general or vascular surgery
Intraoperative
- Mild or moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after standard conventional surgical hemostatic methods prove to be ineffective or impractical.
Exclusion Criteria:
Preoperative
-
Subject needs emergency surgery
-
Subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery
-
Subject will undergo neurological or ophthalmological surgery
-
Subject will undergo urological or gynecological surgery
-
Subject has congenital coagulation disorder
-
Subject is pregnant or lactating at the time of enrollment, or becomes pregnant prior to the planned surgery
Intraoperative:
-
Occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of target bleeding site
-
Disseminated intravascular coagulopathy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 2 | University of Florida College of Medicine | Gainesville | Florida | United States | 32610 |
| 3 | River City Clinical Research | Jacksonville | Florida | United States | 32207 |
| 4 | Jacksonville Center for Clinical Research | Jacksonville | Florida | United States | 32216 |
| 5 | Infectious Disease of Indiana, PSC | Carmel | Indiana | United States | 46032 |
| 6 | University of Kentucky College of Medicine, Kentucky Clinic | Lexington | Kentucky | United States | 40536 |
| 7 | Baystate Medical Center | Springfield | Massachusetts | United States | 01199 |
| 8 | University of Massachusetts Medical School | Worcester | Massachusetts | United States | 01655 |
| 9 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 10 | MCVI at Covenant Medical Center | Saginaw | Michigan | United States | 48602 |
| 11 | Truman Medical Center | Kansas City | Missouri | United States | 64108 |
| 12 | Carolinas Medical Center | Charlotte | North Carolina | United States | 28203 |
| 13 | Christ Hospital, Carl and Edyth Lindner Research Center | Cincinnati | Ohio | United States | 45219 |
| 14 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
| 15 | University of North Texas Science Center | Fort Worth | Texas | United States | 76107 |
| 16 | Houston Methodist Hospital | Houston | Texas | United States | 77030 |
| 17 | Texas Heart Institute, Baylor St. Luke's Medical Center | Houston | Texas | United States | 77030 |
| 18 | Lake Washington Vascular | Bellevue | Washington | United States | 98004 |
| 19 | Froedtert & The Medical College of Wisconsin Clinical Cancer Center | Milwaukee | Wisconsin | United States | 53226 |
| 20 | University Hospital Kralovske Vinohrady, Clinic of Surgery | Prague | Czechia | ||
| 21 | University Hosptial Kralovske Vinohrady, Clinic of Cardiac Surgery | Prague | Czechia | ||
| 22 | DRK Clinics Berlin, Clinic of Surgery | Berlin | Germany | ||
| 23 | Johann Wolfgang Goethe University Hospital, Clinic of General and Visceral Surgery | Frankfurt-am-Main | Germany | ||
| 24 | Non-Public Specialist Healthcare Facility "MEDICUS" | Sroda Wielkopolska | Poland | ||
| 25 | Independent Public Teaching Hospital #2, Department of Vascular and General Surgery and Angiology | Szczecin | Poland |
Sponsors and Collaborators
- Baxter Healthcare Corporation
Investigators
- Study Director: Qing Li, MD, Baxter Healthcare Corporation
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT02640235
Other Study ID Numbers:
- 3584-001
First Posted:
Dec 28, 2015
Last Update Posted:
Aug 3, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Baxter Healthcare Corporation
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | CELSTAT | Surgicel Original |
|---|---|---|
| Arm/Group Description | Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT | Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original |
| Period Title: Overall Study | ||
| STARTED | 131 | 129 |
| COMPLETED | 117 | 115 |
| NOT COMPLETED | 14 | 14 |
Baseline Characteristics
| Arm/Group Title | CELSTAT | Surgicel Original | Total |
|---|---|---|---|
| Arm/Group Description | Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT | Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original | Total of all reporting groups |
| Overall Participants | 126 | 124 | 250 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
63.5
(12.88)
|
63.3
(13.56)
|
63.4
(13.19)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
42
33.3%
|
48
38.7%
|
90
36%
|
| Male |
84
66.7%
|
76
61.3%
|
160
64%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| American Indian or |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Black or African |
15
11.9%
|
12
9.7%
|
27
10.8%
|
| White |
108
85.7%
|
109
87.9%
|
217
86.8%
|
| Native Hawaiian or |
1
0.8%
|
0
0%
|
1
0.4%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Not Applicable |
2
1.6%
|
3
2.4%
|
5
2%
|
Outcome Measures
| Title | Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application |
|---|---|
| Description | Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding. |
| Time Frame | 5 minute (post-application) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS |
| Arm/Group Title | CELSTAT | Surgicel Original |
|---|---|---|
| Arm/Group Description | Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT | Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original |
| Measure Participants | 126 | 124 |
| Yes |
94
74.6%
|
109
87.9%
|
| No |
32
25.4%
|
15
12.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CELSTAT, Surgicel Original |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | The logistic regression estimates are generated from predicted values of the fitted logistic regression model. If the lower bound of the 95% confidence interval is greater than -10, Celstat is non-inferior to Surgicel. If the lower bound of the 95% confidence interval is greater than 0, Celstat will be declared superior to Surgicel. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in avg predicted proportion |
| Estimated Value | -8.5 | |
| Confidence Interval |
(2-Sided) 95% -15.6 to -1.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration |
|---|---|
| Description | Findings are reported in this outcome measure and would have also been reported as an AE. |
| Time Frame | Day 1 to Day 91 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set - all subjects who were treated with CELSTAT or Surgicel. |
| Arm/Group Title | CELSTAT | Surgicel Original |
|---|---|---|
| Arm/Group Description | Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT | Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original |
| Measure Participants | 133 | 127 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants |
|---|---|
| Description | Data presented is an interpretation of a Kaplan-Meier plot based on quartiles of the survival distribution estimate. "Survival" times need not relate to actual survival with death being the event; the "event" may be any event of interest. The Kaplan-Meier curves and estimates of survival data have become a familiar way of dealing with differing survival times (times-to-event). |
| Time Frame | 0 to 10 minutes (post-application) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS |
| Arm/Group Title | CELSTAT | Surgicel Original |
|---|---|---|
| Arm/Group Description | Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT | Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original |
| Measure Participants | 126 | 124 |
| 75% of Patients |
6
|
4
|
| 50% of Patients |
2
|
3
|
| 25% of Patients |
0.833
|
1.292
|
| Title | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application |
|---|---|
| Description | The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application. |
| Time Frame | 3 minutes (post application) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS |
| Arm/Group Title | CELSTAT | Surgicel Original |
|---|---|---|
| Arm/Group Description | Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT | Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original |
| Measure Participants | 126 | 124 |
| Yes |
84
66.7%
|
79
63.7%
|
| No |
42
33.3%
|
45
36.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CELSTAT, Surgicel Original |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in avg predicted proportion |
| Estimated Value | 4.7 | |
| Confidence Interval |
(2-Sided) 95% -3.6 to 13.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application |
|---|---|
| Description | The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application. |
| Time Frame | 7 minutes (post application) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS |
| Arm/Group Title | CELSTAT | Surgicel Original |
|---|---|---|
| Arm/Group Description | Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT | Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original |
| Measure Participants | 126 | 124 |
| Yes |
108
85.7%
|
118
95.2%
|
| No |
18
14.3%
|
6
4.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CELSTAT, Surgicel Original |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in avg predicted proportion |
| Estimated Value | -6.2 | |
| Confidence Interval |
(2-Sided) 95% -12 to -0.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application |
|---|---|
| Description | The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application. |
| Time Frame | 10 minutes (post application) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS |
| Arm/Group Title | CELSTAT | Surgicel Original |
|---|---|---|
| Arm/Group Description | Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT | Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original |
| Measure Participants | 126 | 124 |
| Yes |
119
94.4%
|
120
96.8%
|
| No |
7
5.6%
|
4
3.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CELSTAT, Surgicel Original |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in avg predicted proportion |
| Estimated Value | -0.7 | |
| Confidence Interval |
(2-Sided) 95% -5.7 to 4.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis |
|---|---|
| Description | If intraoperative re-bleeding occurred, the primary endpoint was considered "treatment failure." |
| Time Frame | 0 to 10 minutes (post-application) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS |
| Arm/Group Title | CELSTAT | Surgicel Original |
|---|---|---|
| Arm/Group Description | Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT | Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original |
| Measure Participants | 126 | 124 |
| Yes |
3.3
2.6%
|
2.5
2%
|
| No |
96.7
76.7%
|
97.5
78.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CELSTAT, Surgicel Original |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in avg predicted proportion |
| Estimated Value | 0.2 | |
| Confidence Interval |
(2-Sided) 95% -3.9 to 4.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious) |
|---|---|
| Description | Adverse Events (AEs) that occurred after the start of study treatment application are referred to as "treatment-emergent AEs" (TEAE). Timeframe for tracking AE's up to Day 91 (minus/plus 10 days=from Day 81 to Day 101). |
| Time Frame | Day 1 to Day 91 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set |
| Arm/Group Title | CELSTAT | Surgicel Original |
|---|---|---|
| Arm/Group Description | Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT | Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original |
| Measure Participants | 133 | 127 |
| Number [events] |
289
|
244
|
Adverse Events
| Time Frame | Day 1 up to Day 101 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety Analysis Set used. | |||
| Arm/Group Title | CELSTAT | Surgicel Original | ||
| Arm/Group Description | Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT | Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original | ||
All Cause Mortality |
||||
| CELSTAT | Surgicel Original | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/133 (1.5%) | 3/127 (2.4%) | ||
Serious Adverse Events |
||||
| CELSTAT | Surgicel Original | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 27/133 (20.3%) | 23/127 (18.1%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Leukocytosis | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Cardiac disorders | ||||
| Acute Myocardial Infarction | 2/133 (1.5%) | 2 | 0/127 (0%) | 0 |
| Angina Pectoris | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Atrial Fibrillation | 2/133 (1.5%) | 2 | 3/127 (2.4%) | 3 |
| Atrioventricular Block Complete | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Bradycardia | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Cardiac Arrest | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Cardiac Failure Congestive | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Pulseless Electrical Activity | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Supraventricular Tachycardia | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Tachycardia | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Gastrointestinal disorders | ||||
| Enterovesical Fistula | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Gastrointestinal Haemorrhage | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| General disorders | ||||
| Chest Pain | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Impaired Healing | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Multi-Organ Failure | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Pyrexia | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Thrombosis In Device | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Infections and infestations | ||||
| Bronchitis | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Cellulitis | 1/133 (0.8%) | 1 | 2/127 (1.6%) | 2 |
| Pneumonia | 1/133 (0.8%) | 1 | 2/127 (1.6%) | 2 |
| Postoperative Wound Infection | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Sepsis | 2/133 (1.5%) | 2 | 0/127 (0%) | 0 |
| Urinary Tract Infection | 2/133 (1.5%) | 2 | 0/127 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Post Procedural Haemorrhage | 1/133 (0.8%) | 1 | 2/127 (1.6%) | 2 |
| Postoperative Thoracic Procedure Complication | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Vascular Graft Occlusion | 2/133 (1.5%) | 2 | 0/127 (0%) | 0 |
| Vascular Graft Thrombosis | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Wound Dehiscence | 0/133 (0%) | 0 | 2/127 (1.6%) | 2 |
| Metabolism and nutrition disorders | ||||
| Hypocalcaemia | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Lung Adenocarcinoma Metastatic | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Metastases To Liver | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Nervous system disorders | ||||
| Cerebrovascular Accident | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Encephalopathy | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Partial Seizures | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Syncope | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Tremor | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Renal and urinary disorders | ||||
| Acute Kidney Injury | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Chronic Kidney Disease | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Vaginal Haemorrhage | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute Respiratory Failure | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Pleural Effusion | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Pneumothorax | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Pulmonary Embolism | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Erythema | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Vascular disorders | ||||
| Aortic Occlusion | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Lymphorrhoea | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Orthostatic Hypotension | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Peripheral Arterial Occlusive | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Peripheral Artery Stenosis | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Peripheral Vascular Disorder | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| CELSTAT | Surgicel Original | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 72/133 (54.1%) | 68/127 (53.5%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 5/133 (3.8%) | 5 | 6/127 (4.7%) | 6 |
| Coagulopathy | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Haemolysis | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Haemorrhagic Anaemia | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Leukocytosis | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Lymphadenopathy | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Thrombocytopenia | 2/133 (1.5%) | 2 | 1/127 (0.8%) | 1 |
| Thrombocytosis | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Cardiac disorders | ||||
| Acute Myocardial Infarction | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Atrial Fibrillation | 16/133 (12%) | 16 | 13/127 (10.2%) | 13 |
| Atrial Flutter | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Bradycardia | 1/133 (0.8%) | 1 | 2/127 (1.6%) | 2 |
| Cardiac Failure Acute | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Cardiac Tamponade | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Cardiogenic Shock | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Mitral Valve Incompetence | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Nodal Rhythm | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Pericardial Effusion | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Supraventricular Tachycardia | 0/133 (0%) | 0 | 2/127 (1.6%) | 2 |
| Tachycardia | 3/133 (2.3%) | 3 | 1/127 (0.8%) | 1 |
| Ventricular Tachycardia | 0/133 (0%) | 0 | 2/127 (1.6%) | 2 |
| Ear and labyrinth disorders | ||||
| Tinnitus | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Vertigo | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Vertigo Positional | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Eye disorders | ||||
| Conjunctival Haemorrhage | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Vision Blurred | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal Distension | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Abdominal Mass | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Abdominal Pain | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Acquired Oesophageal Web | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Ascites | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Constipation | 2/133 (1.5%) | 2 | 5/127 (3.9%) | 5 |
| Diarrhoea | 6/133 (4.5%) | 6 | 3/127 (2.4%) | 3 |
| Diverticulum | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Dysphagia | 1/133 (0.8%) | 1 | 3/127 (2.4%) | 3 |
| Gastrointestinal Haemorrhage | 3/133 (2.3%) | 3 | 0/127 (0%) | 0 |
| Gastrooesophageal Reflux Disease | 2/133 (1.5%) | 2 | 1/127 (0.8%) | 1 |
| Haemorrhoids | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Ileus | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Impaired Gastric Emptying | 2/133 (1.5%) | 2 | 0/127 (0%) | 0 |
| Nausea | 9/133 (6.8%) | 9 | 4/127 (3.1%) | 4 |
| Rectal Haemorrhage | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Vomiting | 2/133 (1.5%) | 2 | 2/127 (1.6%) | 2 |
| General disorders | ||||
| Asthenia | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Catheter Site Pain | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Chest Pain | 2/133 (1.5%) | 2 | 4/127 (3.1%) | 4 |
| Device Leakage | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Device Occlusion | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Fatigue | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| General Physical Health Deterioration | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Hyperthermia | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Impaired Healing | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Implant Site Pain | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Implant Site Swelling | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Mucosal Inflammation | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Oedema Peripheral | 3/133 (2.3%) | 3 | 3/127 (2.4%) | 3 |
| Peripheral Swelling | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Polyp | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Pyrexia | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Stent-Graft Endoleak | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Cholelithiasis | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Hyperbilirubinaemia | 2/133 (1.5%) | 2 | 1/127 (0.8%) | 1 |
| Ischaemic Hepatitis | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Immune system disorders | ||||
| Drug Hypersensitivity | 2/133 (1.5%) | 2 | 0/127 (0%) | 0 |
| Infections and infestations | ||||
| Bronchitis | 2/133 (1.5%) | 2 | 1/127 (0.8%) | 1 |
| Cellulitis | 0/133 (0%) | 0 | 2/127 (1.6%) | 2 |
| Clostridium Difficile Colitis | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Endometritis | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Fungal Skin Infection | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Gastritis Viral | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Gastrointestinal Infection | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Groin Infection | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Implant Site Infection | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Incision Site Infection | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Liver Abscess | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Oral Candidiasis | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Oral Fungal Infection | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Pneumonia | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Post Procedural Cellulitis | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Postoperative Abscess | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Postoperative Wound Infection | 2/133 (1.5%) | 2 | 1/127 (0.8%) | 1 |
| Sinusitis | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Soft Tissue Infection | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Urinary Tract Infection | 4/133 (3%) | 4 | 6/127 (4.7%) | 6 |
| Viral Upper Respiratory Tract Infection | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Wound Infection | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Anaemia Postoperative | 4/133 (3%) | 4 | 4/127 (3.1%) | 4 |
| Corneal Abrasion | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Fall | 0/133 (0%) | 0 | 2/127 (1.6%) | 2 |
| Incision Site Erythema | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Incision Site Swelling | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Inflammation Of Wound | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Post Procedural Discharge | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Post Procedural Haemorrhage | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Postoperative Ileus | 3/133 (2.3%) | 3 | 1/127 (0.8%) | 1 |
| Postoperative Wound Complication | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Procedural Dizziness | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Procedural Haemorrhage | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Procedural Hypotension | 4/133 (3%) | 4 | 6/127 (4.7%) | 6 |
| Procedural Nausea | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Procedural Pain | 2/133 (1.5%) | 2 | 0/127 (0%) | 0 |
| Rib Fracture | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Seroma | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Skin Abrasion | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Wound | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Wound Dehiscence | 2/133 (1.5%) | 2 | 0/127 (0%) | 0 |
| Wound Haematoma | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Wound Secretion | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Investigations | ||||
| Alanine Aminotransferase Increased | 1/133 (0.8%) | 1 | 2/127 (1.6%) | 2 |
| Anticoagulation Drug Level Below Therapeutic | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Blood Alkaline Phosphatase Increased | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Blood Creatinine Increased | 0/133 (0%) | 0 | 2/127 (1.6%) | 2 |
| Blood Gases Abnormal | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Blood Glucose Increased | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Blood Parathyroid Hormone Increased | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Blood Potassium Decreased | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Blood Urea Increased | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Breath Sounds Abnormal | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Cardiac Index Decreased | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Heart Rate Increased | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Transaminases Increased | 1/133 (0.8%) | 1 | 2/127 (1.6%) | 2 |
| Urine Output Decreased | 0/133 (0%) | 0 | 2/127 (1.6%) | 2 |
| Weight Decreased | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| White Blood Cell Count Increased | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Decreased Appetite | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Dehydration | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Electrolyte Imbalance | 2/133 (1.5%) | 2 | 0/127 (0%) | 0 |
| Fluid Overload | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Gout | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Hyperglycaemia | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Hyperkalaemia | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Hypermagnesaemia | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Hypernatraemia | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Hypocalcaemia | 1/133 (0.8%) | 1 | 3/127 (2.4%) | 3 |
| Hypoglycaemia | 3/133 (2.3%) | 3 | 3/127 (2.4%) | 3 |
| Hypokalaemia | 7/133 (5.3%) | 7 | 2/127 (1.6%) | 2 |
| Hypomagnesaemia | 3/133 (2.3%) | 3 | 0/127 (0%) | 0 |
| Hyponatraemia | 4/133 (3%) | 4 | 1/127 (0.8%) | 1 |
| Malnutrition | 0/133 (0%) | 0 | 2/127 (1.6%) | 2 |
| Metabolic Acidosis | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Vitamin D Deficiency | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 2/133 (1.5%) | 2 | 0/127 (0%) | 0 |
| Arthritis | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Muscular Weakness | 2/133 (1.5%) | 2 | 1/127 (0.8%) | 1 |
| Musculoskeletal Pain | 2/133 (1.5%) | 2 | 0/127 (0%) | 0 |
| Neck Pain | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Prostate Cancer | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Nervous system disorders | ||||
| Carotid Artery Stenosis | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Carpal Tunnel Syndrome | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Cerebrovascular Accident | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Dizziness | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Dizziness Postural | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Dysgeusia | 2/133 (1.5%) | 2 | 0/127 (0%) | 0 |
| Headache | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Hypoaesthesia | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Hypoglossal Nerve Disorder | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Neuralgia | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Paraesthesia | 1/133 (0.8%) | 1 | 3/127 (2.4%) | 3 |
| Restless Legs Syndrome | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Psychiatric disorders | ||||
| Anxiety | 2/133 (1.5%) | 2 | 2/127 (1.6%) | 2 |
| Confusional State | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Delirium | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Depression | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Insomnia | 2/133 (1.5%) | 2 | 1/127 (0.8%) | 1 |
| Renal and urinary disorders | ||||
| Acute Kidney Injury | 4/133 (3%) | 4 | 2/127 (1.6%) | 2 |
| Calculus Bladder | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Chronic Kidney Disease | 0/133 (0%) | 0 | 2/127 (1.6%) | 2 |
| Dysuria | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Haematuria | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Oliguria | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Renal Cyst | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Urinary Retention | 2/133 (1.5%) | 2 | 3/127 (2.4%) | 3 |
| Reproductive system and breast disorders | ||||
| Epididymal Tenderness | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Scrotal Swelling | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute Respiratory Failure | 2/133 (1.5%) | 2 | 1/127 (0.8%) | 1 |
| Atelectasis | 0/133 (0%) | 0 | 4/127 (3.1%) | 4 |
| Cough | 2/133 (1.5%) | 2 | 1/127 (0.8%) | 1 |
| Dyspnoea | 4/133 (3%) | 4 | 1/127 (0.8%) | 1 |
| Epistaxis | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Hypoxia | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Lung Infiltration | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Pleural Effusion | 6/133 (4.5%) | 6 | 6/127 (4.7%) | 6 |
| Pneumothorax | 1/133 (0.8%) | 1 | 2/127 (1.6%) | 2 |
| Productive Cough | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Pulmonary Embolism | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Pulmonary Hypertension | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Respiratory Distress | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Respiratory Failure | 2/133 (1.5%) | 2 | 4/127 (3.1%) | 4 |
| Skin and subcutaneous tissue disorders | ||||
| Blister | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Decubitus Ulcer | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Dermatitis Allergic | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Drug Eruption | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Dry Skin | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Hyperhidrosis | 0/133 (0%) | 0 | 2/127 (1.6%) | 2 |
| Pruritus | 1/133 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Pruritus Allergic | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Pruritus Generalised | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Psoriasis | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Skin Irritation | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Vascular disorders | ||||
| Deep Vein Thrombosis | 2/133 (1.5%) | 2 | 0/127 (0%) | 0 |
| Haematoma | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Hypertension | 5/133 (3.8%) | 5 | 4/127 (3.1%) | 4 |
| Hypotension | 3/133 (2.3%) | 3 | 3/127 (2.4%) | 3 |
| Hypovolaemic Shock | 1/133 (0.8%) | 1 | 0/127 (0%) | 0 |
| Thrombophlebitis | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
| Vasodilatation | 0/133 (0%) | 0 | 1/127 (0.8%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT 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 | Clinical Trials Disclosure Group |
|---|---|
| Organization | Baxter Healthcare Corporation |
| Phone | (224) 948-7359 |
| Global_CORP_ClinicalTrialsDisclosure@baxter.com |
Responsible Party:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT02640235
Other Study ID Numbers:
- 3584-001
First Posted:
Dec 28, 2015
Last Update Posted:
Aug 3, 2020
Last Verified:
Jul 1, 2020