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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014