Trial Outcomes & Findings for EVARREST™ Fibrin Sealant Patch Post-Market Study (NCT NCT01902459)
NCT ID: NCT01902459
Last Updated: 2018-01-17
Results Overview
Number of subjects experiencing a thromboembolic event as reported in the adverse events/serious adverse event safety set. the Safety set consists of all subjects on whom procedure is started.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
150 participants
Primary outcome timeframe
Surgery up until the 30 day follow-up
Results posted on
2018-01-17
Participant Flow
Subjects were recruited from July 2, 2013 through August 13, 2015 at a single center in the United States
Participant milestones
| Measure |
EVARREST Fibrin Sealant Patch
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
Standard of Care (SoC)
Manual compression with or without a topical absorbable hemostat
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EVARREST™ Fibrin Sealant Patch Post-Market Study
Baseline characteristics by cohort
| Measure |
EVARREST Fibrin Sealant Patch
n=75 Participants
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
Standard of Care (SoC)
n=75 Participants
Manual compression with or without a topical absorbable hemostat
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to < 50 years
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Customized
50 to < 65 years
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Customized
65 to < 75 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Customized
>= 75 yeatrs
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White / Caucasian
|
69 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI Category
Underweight
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
BMI Category
Normal
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
BMI Category
Overweight
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
BMI Category
Obese
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
BMI Category
Morbidly obese
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Surgery up until the 30 day follow-upNumber of subjects experiencing a thromboembolic event as reported in the adverse events/serious adverse event safety set. the Safety set consists of all subjects on whom procedure is started.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=75 Participants
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
Standard of Care (SoC)
n=75 Participants
Manual compression with or without a topical absorbable hemostat
|
|---|---|---|
|
Safety Parameter - Incidence of Thromboembolic Events
|
2 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Surgery up until the 30 day follow-upNumber of subjects experiencing a post-operative bleeding event specifically related to the target bleeding site (TBS) and as reported in the adverse events/serious adverse event safety set. Safety set consisting of all subjects on whom procedure is started.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=75 Participants
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
Standard of Care (SoC)
n=75 Participants
Manual compression with or without a topical absorbable hemostat
|
|---|---|---|
|
Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Surgery up until the 30 day follow-upNumber of subjects experiencing an increase in blood fibrinogen from the safety set consisting of all subjects on whom procedure is started.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=75 Participants
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
Standard of Care (SoC)
n=75 Participants
Manual compression with or without a topical absorbable hemostat
|
|---|---|---|
|
Safety Parameter - Incidence of Increase Blood Fibrinogen Level
|
3 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraoperativeThis product is easy and quick to prepare for application to the target bleeding site.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=75 Participants
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
Standard of Care (SoC)
n=75 Participants
Manual compression with or without a topical absorbable hemostat
|
|---|---|---|
|
This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site.
Disagree
|
0 Participants
|
0 Participants
|
|
This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site.
Neutral
|
0 Participants
|
46 Participants
|
|
This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site.
Strongly Disagree
|
1 Participants
|
5 Participants
|
|
This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site.
Agree
|
12 Participants
|
10 Participants
|
|
This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site.
Strongly Agree
|
62 Participants
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraoperativeThis product is easy to apply to a variety of bleeding sites.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=75 Participants
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
Standard of Care (SoC)
n=75 Participants
Manual compression with or without a topical absorbable hemostat
|
|---|---|---|
|
This Product is Easy to Apply to a Variety of Bleeding Sites.
Strongly Disagree
|
1 Participants
|
5 Participants
|
|
This Product is Easy to Apply to a Variety of Bleeding Sites.
Disagree
|
0 Participants
|
1 Participants
|
|
This Product is Easy to Apply to a Variety of Bleeding Sites.
Neutral
|
0 Participants
|
46 Participants
|
|
This Product is Easy to Apply to a Variety of Bleeding Sites.
Agree
|
10 Participants
|
9 Participants
|
|
This Product is Easy to Apply to a Variety of Bleeding Sites.
Strongly Agree
|
64 Participants
|
13 Participants
|
|
This Product is Easy to Apply to a Variety of Bleeding Sites.
Not applicable
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraoperativeThis product is easy to cut to size for application on various sized bleeding sites e.g., a customized preparation.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=75 Participants
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
Standard of Care (SoC)
n=75 Participants
Manual compression with or without a topical absorbable hemostat
|
|---|---|---|
|
This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.
Strongly Agree
|
66 Participants
|
15 Participants
|
|
This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.
Strongly Disagree
|
1 Participants
|
5 Participants
|
|
This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.
Disagree
|
0 Participants
|
0 Participants
|
|
This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.
Neutral
|
0 Participants
|
45 Participants
|
|
This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.
Agree
|
7 Participants
|
8 Participants
|
|
This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.
Not applicable
|
1 Participants
|
2 Participants
|
Adverse Events
EVARREST Fibrin Sealant Patch
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Standard of Care (SoC)
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EVARREST Fibrin Sealant Patch
n=75 participants at risk
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
Standard of Care (SoC)
n=75 participants at risk
Manual compression with or without a topical absorbable hemostat
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
4.0%
3/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
4.0%
3/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
|
Cardiac disorders
Intracardiac thrombus
|
1.3%
1/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
1/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.3%
1/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
1.3%
1/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
Other adverse events
| Measure |
EVARREST Fibrin Sealant Patch
n=75 participants at risk
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
Standard of Care (SoC)
n=75 participants at risk
Manual compression with or without a topical absorbable hemostat
|
|---|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.3%
1/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
1.3%
1/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
1.3%
1/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
|
Vascular disorders
Haematoma
|
1.3%
1/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
|
Vascular disorders
Deep vein thrombosis
|
1.3%
1/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
6.7%
5/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
4.0%
3/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
1/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
|
Cardiac disorders
Intracardiac thrombus
|
1.3%
1/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
1/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
0.00%
0/75 • Surgical procedure through 30 (+/- 24 days) post surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60