The Fibrin Pad Cardiovascular Study

NCT01681030 | Completed Phase 2 Results DMC

• 1 other identifier: 400-12-002
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 6

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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Hemostasis at the Target Bleeding Site (TBS) 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

  Intraoperative, 10 minutes following treatment application

• Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment

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

• Number of Participants With Adverse Events Potentially Related to Thrombotic Events

  30 days (+ 14 days) following surgery

Study Arms (3)

EVARREST™

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™

Topical hemostat

ACTIVE COMPARATOR

Equine collagen with Human Fibrinogen and Human Thrombin

Biological: Topical hemostat

Standard of Care

ACTIVE COMPARATOR

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

Interventions

EVARREST™ BIOLOGICAL

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).

EVARREST™

Topical hemostat BIOLOGICAL

Equine collagen with Human Fibrinogen and Human Thrombin

Topical hemostat

Standard of Care OTHER

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.

Standard of Care

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 must be willing to participate in the study and provide written informed consent.

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 30 day follow up period after surgery.
• Female subjects who are pregnant or nursing.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (6)

Clinical Investigation Site #5

Indianapolis, Indiana, 46260, United States

Location

Clinical Investigation Site #6

Kansas City, Missouri, 64111, United States

Location

Clinical Investigation Site #4

Camden, New Jersey, 08103, United States

Location

Clinical Investigation Site #1

Paterson, New Jersey, 07503, United States

Location

Clinical Investigation Site #3

New York, New York, 10016, United States

Location

Clinical Investigation Site #2

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Fibrin Tissue Adhesive; Standard of Care

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

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

rkochar1@its.jnj.com

+1-908-218-2013

Study Officials

• Jerome Riebman, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 7, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 3, 2013
• Last Updated: June 12, 2018
• Results First Posted: March 7, 2018

Record last verified: 2018-05

Locations

US (6)