The Fibrin Pad CV Phase III Study

NCT02040428 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: BIOS-13-0042013-003464-31
• Study Type: interventional
• Target: 156
• Locations: 5 countries
• Sites: 24

Brief Summary

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.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular Diseases; Fibrin Sealant; Hemostatics; Coagulants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application

  Intraoperative, 6 minutes following treatment application

• Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application

  Intraoperative, 10 minutes following treatment application

• Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment

  Intra-operative, prior initiation of final chest wall closure.

Study Arms (2)

EVARREST™ Fibrin Sealant Patch

EXPERIMENTAL

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

Topical hemostat

ACTIVE COMPARATOR

Equine collagen with Human Fibrinogen and Human Thrombin

Biological: Topical hemostat

Interventions

EVARREST™ Fibrin Sealant Patch BIOLOGICAL

EVARREST™ Fibrin Sealant Patch

Topical hemostat BIOLOGICAL

Topical hemostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (24)

Clinical Investigation Site #15

Atlanta, Georgia, 30342, United States

Location

Clinical Investigation Site #14

Indianapolis, Indiana, 46290, United States

Location

Clinical Investigation Site #16

Baltimore, Maryland, 21201, United States

Location

Clinical Investigation Site #21

Bethesda, Maryland, 20814, United States

Location

Clinical Investigation Site #17

St Louis, Missouri, 63110, United States

Location

Clinical Investigation Site #10

Paterson, New Jersey, 07503, United States

Location

Clinical Investigation Site #12

New York, New York, 10016, United States

Location

Clinical Investigation Site #20

Philadelphia, Pennsylvania, 19102, United States

Location

Clinical Investigation Site #18

Houston, Texas, 77030, United States

Location

Clinical Investigation Site #72

Camperdown, New South Wales, 2050, Australia

Location

Clinical Investigation Site #73

Sydney, New South Wales, 2010, Australia

Location

Clinical Investigation Site #71

Brisbane, Queensland, 4000, Australia

Location

Clinical Investigation Site #74

Bedford Park, South Australia, 5042, Australia

Location

Clinical Investigation Site #70

Melbourne, Victoria, 3050, Australia

Location

Clinical Investigation Site #40

Ghent, 9000, Belgium

Location

Clinical Investigation Site #82

Kanagawa, Isehara-shi, Japan

Location

Clinical Investigation Site #81

Saitama, Saitama-shi, Japan

Location

Clinical Investigation Site #80

Osaka, Suita-shi, Japan

Location

Clinical Investigation Site #33

Bristol, England, BS2 8HW, United Kingdom

Location

Clinical Investigation Site #35

Cottingham, England, HU16 5JQ, United Kingdom

Location

Clinical Investigation Site #34

Manchester, England, M13 9WL, United Kingdom

Location

Clinical Investigation Site #32

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Clinical Investigation Site #31

Clydebank, Scotland, G81 4DY, United Kingdom

Location

Clinical Investigation Site #30

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Richard Kocharian, MD, PhD
• Organization: Ethicon, Inc.

rkochar1@ITS.JNJ.com

1 (908) 218-2013

Study Officials

• Richard Kocharian, MD, PhD

  Ethicon, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 20, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 15, 2017
• Results First Posted: August 15, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (3); GB (6); US (9); AU (5); BE (1)