The Fibrin Pad Cardiovascular Study

• ClinicalTrials.gov Identifier: NCT01681030
• Recruitment Status: Completed
• First Posted: September 7, 2012
• Results First Posted: March 7, 2018
• Last Update Posted: June 12, 2018
• Sponsor: Ethicon, Inc.
• Information provided by (Responsible Party): Ethicon, Inc.

Study Description

Brief Summary:

This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Disease	Biological: EVARREST™; Biological: Topical hemostat; Other: Standard of Care	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Controlled, Comparative Phase II Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
• Actual Study Start Date: August 1, 2012
• Actual Primary Completion Date: August 1, 2013
• Actual Study Completion Date: September 3, 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: EVARREST™; 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).	Biological: EVARREST™; 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).
Active Comparator: Topical hemostat; Equine collagen with Human Fibrinogen and Human Thrombin	Biological: Topical hemostat; Equine collagen with Human Fibrinogen and Human Thrombin
Active Comparator: Standard of Care; 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.	Other: Standard of Care; 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.

Outcome Measures

Primary Outcome Measures :

1. Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. [ Time Frame: Intraoperative, 3 minutes following treatment application ]
   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

Secondary Outcome Measures :

1. Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application [ Time Frame: Intraoperative, 6 minutes following treatment application ]
   The number of subjects achieving hemostatic success at 6 minutes following treatment application.
2. Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application [ Time Frame: Intraoperative, 10 minutes following treatment application ]
   Number of subjects achieving hemostatic success at 10 minutes following treatment application.
3. Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment [ Time Frame: Intra-operative, prior initiation of final chest wall closure. Safety Issue: ]
   The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had re-bleeding requiring treatment
4. Number of Participants With Adverse Events Potentially Related to Thrombotic Events [ Time Frame: 30 days (+ 14 days) following surgery ]
   The number of subjects with an adverse event potentially related to a thrombotic event

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass;
• Subjects must be willing to participate in the study and provide written informed consent.

Exclusion Criteria:

• Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
• Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 30 day follow up period after surgery.
• Female subjects who are pregnant or nursing.

Contacts and Locations

Locations

United States, Indiana

Clinical Investigation Site #5

Indianapolis, Indiana, United States, 46260

United States, Missouri

Clinical Investigation Site #6

Kansas City, Missouri, United States, 64111

United States, New Jersey

Clinical Investigation Site #4

Camden, New Jersey, United States, 08103

Clinical Investigation Site #1

Paterson, New Jersey, United States, 07503

United States, New York

Clinical Investigation Site #3

New York, New York, United States, 10016

Clinical Investigation Site #2

New York, New York, United States, 10075

Sponsors and Collaborators

Ethicon, Inc.

Investigators

• Study Director: Jerome Riebman, MD; Ethicon, Inc.

More Information

• Responsible Party: Ethicon, Inc.
• ClinicalTrials.gov Identifier: NCT01681030
• Other Study ID Numbers: 400-12-002
• First Posted: September 7, 2012
• Results First Posted: March 7, 2018
• Last Update Posted: June 12, 2018
• Last Verified: May 2018

Additional relevant MeSH terms:

Cardiovascular Diseases; Fibrin Tissue Adhesive; Hemostatics; Coagulants