The Fibrin Pad Cardiovascular Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01681030
First received: September 5, 2012
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Cardiovascular Disease
Biological: EVARREST™
Biological: Topical hemostat
Other: Standard of Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Hemostasis at the Target Bleeding Site (TBS) at 3-minutes following treatment application [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]
    Hemostasis at the TBS at 3-minutes following treatment application and with no re-bleeding requiring treatment at the TBS any time prior to initiation of final chest wall closure. Hemostasis is defined as no detectable bleeding at the TBS.


Enrollment: 42
Study Start Date: August 2012
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681030

Locations
United States, Indiana
Clinical Investigation Site #5
Indianopolis, 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

No publications provided

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01681030     History of Changes
Other Study ID Numbers: 400-12-002
Study First Received: September 5, 2012
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cardiovascular Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014