The Fibrin Pad CV Phase III Study

A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery

The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Biological: EVARREST™ Fibrin Sealant Patch; Biological: Topical hemostat

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Clinical Investigation Site #72
    • Sydney, New South Wales, Australia, 2010
      • Clinical Investigation Site #73
  • Queensland
    • Brisbane, Queensland, Australia, 4000
      • Clinical Investigation Site #71
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Clinical Investigation Site #74
  • Victoria
    • Melbourne, Victoria, Australia, 3050
      • Clinical Investigation Site #70
• Belgium
  • Gent, Belgium, 9000
    • Clinical Investigation Site #40
• Japan
  • Isehara-shi
    • Kanagawa, Isehara-shi, Japan
      • Clinical Investigation Site #82
  • Saitama-shi
    • Saitama, Saitama-shi, Japan
      • Clinical Investigation Site #81
  • Suita-shi
    • Osaka, Suita-shi, Japan
      • Clinical Investigation Site #80
• United Kingdom
  • England
    • Bristol, England, United Kingdom, BS2 8HW
      • Clinical Investigation Site #33
    • Cottingham, England, United Kingdom, HU16 5JQ
      • Clinical Investigation Site #35
    • Manchester, England, United Kingdom, M13 9WL
      • Clinical Investigation Site #34
  • Scotland
    • Aberdeen, Scotland, United Kingdom, AB25 2ZN
      • Clinical Investigation Site #32
    • Clydebank, Scotland, United Kingdom, G81 4DY
      • Clinical Investigation Site #31
    • Edinburgh, Scotland, United Kingdom, EH16 4SA
      • Clinical Investigation Site #30
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Clinical Investigation Site #15
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Clinical Investigation Site #14
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Clinical Investigation Site #16
    • Bethesda, Maryland, United States, 20814
      • Clinical Investigation Site #21
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Clinical Investigation Site #17
  • New Jersey
    • Paterson, New Jersey, United States, 07503
      • Clinical Investigation Site #10
  • New York
    • New York, New York, United States, 10016
      • Clinical Investigation Site #12
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Clinical Investigation Site #20
  • Texas
    • Houston, Texas, United States, 77030
      • Clinical Investigation Site #18

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 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 in Japan between ≥18 and <20 years of age will require consent by the subject's legal representative
• Subjects must be willing to participate in the study and provide written informed consent.
• Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator;

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 60 day follow up period after surgery.
• Female subjects who are pregnant or nursing.
• TBS is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure during absorption of the product;
• TBS with major arterial bleeding requiring suture or mechanical ligation;
• TBS involves an expanded polytetrafluoroethylene (ePTFE) graft
• TBS within an actively infected field;
• Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
• Subjects with any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Biological: EVARREST™ Fibrin Sealant Patch
Active Comparator: Topical hemostat; Equine collagen with Human Fibrinogen and Human Thrombin	Biological: Topical hemostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 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 closure	Intraoperative, 3 minutes following treatment application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 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 with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.	Intraoperative, 6 minutes following treatment application
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application	The number of subjects achieving hemostatic success at 10 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.	Intraoperative, 10 minutes following treatment application
Number of Participants With Re-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 intra-operative re-bleeding requiring treatment at the TBS	Intra-operative, prior initiation of final chest wall closure.

Collaborators and Investigators

• Sponsor: Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Actual): August 15, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Fibrin Sealant; Hemostatics; Coagulants
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: BIOS-13-004; 2013-003464-31 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No