The Fibrin Pad Cardiovascular Study

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Biological: EVARREST™; Biological: Topical hemostat; Other: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Clinical Investigation Site #5
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Clinical Investigation Site #6
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Clinical Investigation Site #4
    • Paterson, New Jersey, United States, 07503
      • Clinical Investigation Site #1
  • New York
    • New York, New York, United States, 10016
      • Clinical Investigation Site #3
    • New York, New York, United States, 10075
      • Clinical Investigation Site #2

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topical hemostat; Equine collagen with Human Fibrinogen and Human Thrombin	Biological: Topical hemostat; Equine collagen with Human Fibrinogen and Human Thrombin
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostasis at the Target Bleeding Site (TBS) at 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	Intraoperative, 3 minutes following treatment application

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Investigators: Study Director: Jerome Riebman, MD, Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): September 3, 2013

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: September 6, 2012
• First Posted (Estimate): September 7, 2012

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: 400-12-002