Trial Outcomes & Findings for The Fibrin Pad Cardiovascular Study (NCT NCT01681030)

Last Updated: 2018-06-12

Results Overview

Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closur

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

Intraoperative, 3 minutes following treatment application

Results posted on

2018-06-12

Participant Flow

Subjects were recruited from September 17, 2012 through September 3, 2013 at hospitals and medical centers throughout the United States.

Participant milestones

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.	Topical Hemostat Equine collagen sponge with Human Fibrinogen and Human Thrombin	Standard of Care (SoC) SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
Overall Study STARTED	13	18	11
Overall Study COMPLETED	13	18	11
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Fibrin Pad Cardiovascular Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EVARREST Fibrin Sealant Patch n=13 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.	Topical Hemostat n=18 Participants Equine collagen sponge with Human Fibrinogen and Human Thrombin	Standard of Care (SoC) n=11 Participants SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.	Total n=42 Participants Total of all reporting groups
Age, Continuous Age	56.0 Years STANDARD_DEVIATION 15.1 • n=5 Participants	59.8 Years STANDARD_DEVIATION 12.9 • n=7 Participants	60.5 Years STANDARD_DEVIATION 15.4 • n=5 Participants	58.8 Years STANDARD_DEVIATION 14.0 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	15 Participants n=7 Participants	9 Participants n=5 Participants	33 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized White/Caucasian	9 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	26 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
BMI Category Normal	5 Participant n=5 Participants	7 Participant n=7 Participants	4 Participant n=5 Participants	16 Participant n=4 Participants
BMI Category Overweight	3 Participant n=5 Participants	5 Participant n=7 Participants	2 Participant n=5 Participants	10 Participant n=4 Participants
BMI Category Obese	3 Participant n=5 Participants	5 Participant n=7 Participants	4 Participant n=5 Participants	12 Participant n=4 Participants
BMI Category Morbidly obese	2 Participant n=5 Participants	1 Participant n=7 Participants	1 Participant n=5 Participants	4 Participant n=4 Participants

PRIMARY outcome

Timeframe: Intraoperative, 3 minutes following treatment application

Outcome measures

Outcome measures
Measure	EVARREST Fibrin Sealant Patch n=13 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.	Topical Hemostat n=18 Participants Equine collagen sponge with Human Fibrinogen and Human Thrombin	Standard of Care (SoC) n=11 Participants SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.	12 Participants	6 Participants	5 Participants

SECONDARY outcome

Timeframe: Intraoperative, 6 minutes following treatment application

The number of subjects achieving hemostatic success at 6 minutes following treatment application.

Outcome measures

Outcome measures
Measure	EVARREST Fibrin Sealant Patch n=13 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.	Topical Hemostat n=18 Participants Equine collagen sponge with Human Fibrinogen and Human Thrombin	Standard of Care (SoC) n=11 Participants SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application	12 Participants	11 Participants	7 Participants

SECONDARY outcome

Timeframe: Intraoperative, 10 minutes following treatment application

Number of subjects achieving hemostatic success at 10 minutes following treatment application.

Outcome measures

Outcome measures
Measure	EVARREST Fibrin Sealant Patch n=13 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.	Topical Hemostat n=18 Participants Equine collagen sponge with Human Fibrinogen and Human Thrombin	Standard of Care (SoC) n=11 Participants SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application	12 Participants	12 Participants	8 Participants

SECONDARY outcome

Timeframe: Intra-operative, prior initiation of final chest wall closure. Safety Issue:

Population: Subjects who established TBS hemostasis at 3 minutes

The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had re-bleeding requiring treatment

Outcome measures

Outcome measures
Measure	EVARREST Fibrin Sealant Patch n=12 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.	Topical Hemostat n=11 Participants Equine collagen sponge with Human Fibrinogen and Human Thrombin	Standard of Care (SoC) n=5 Participants SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment	0 Participants	5 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days (+ 14 days) following surgery

The number of subjects with an adverse event potentially related to a thrombotic event

Outcome measures

Outcome measures
Measure	EVARREST Fibrin Sealant Patch n=13 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.	Topical Hemostat n=18 Participants Equine collagen sponge with Human Fibrinogen and Human Thrombin	Standard of Care (SoC) n=11 Participants SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
Number of Participants With Adverse Events Potentially Related to Thrombotic Events	0 Participants	2 Participants	2 Participants

Adverse Events

EVARREST Fibrin Sealant Patch

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Topical Hemostat

Serious events: 10 serious events

Other events: 18 other events

Deaths: 0 deaths

Standard of Care (SoC)

Serious events: 6 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Richard Kocharian, MD, PhD

Ethicon, Inc

Phone: +1-908-218-2013

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	EVARREST Fibrin Sealant Patch n=13 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.	Topical Hemostat n=18 participants at risk Equine collagen sponge with Human Fibrinogen and Human Thrombin	Standard of Care (SoC) n=11 participants at risk SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	5.6% 1/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	9.1% 1/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	5.6% 1/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	18.2% 2/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	7.7% 1/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	5.6% 1/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	9.1% 1/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	18.2% 2/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Renal and urinary disorders RENAL FAILURE	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	5.6% 1/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Psychiatric disorders ALCOHOL WITHDRAWAL SYNDROME	15.4% 2/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Nervous system disorders SPINAL CORD ISCHAEMIA	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	5.6% 1/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	9.1% 1/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	11.1% 2/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Infections and infestations PNEUMONIA	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	5.6% 1/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Infections and infestations CLOSTRIDIAL INFECTION	7.7% 1/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Cardiac disorders VENTRICULAR FIBRILLATION	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	9.1% 1/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Cardiac disorders SINUS BRADYCARDIA	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	5.6% 1/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	9.1% 1/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Cardiac disorders CARDIAC TAMPONADE	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	9.1% 1/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	5.6% 1/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Cardiac disorders CARDIAC ARREST	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	9.1% 1/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	16.7% 3/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	9.1% 1/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Cardiac disorders ATRIAL FLUTTER	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	5.6% 1/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Cardiac disorders ATRIAL FIBRILLATION	15.4% 2/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	11.1% 2/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	9.1% 1/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Blood and lymphatic system disorders COAGULOPATHY	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	5.6% 1/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)
Blood and lymphatic system disorders ANAEMIA	0.00% 0/13 • From surgical procedure through the 30 day follow-up (+/- 14 days)	0.00% 0/18 • From surgical procedure through the 30 day follow-up (+/- 14 days)	9.1% 1/11 • From surgical procedure through the 30 day follow-up (+/- 14 days)