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The Fibrin Pad Cardiovascular Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01681030
First Posted: September 7, 2012
Last Update Posted: September 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ethicon, Inc.
  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
Intervention Model: Parallel Assignment
Masking: None (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

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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01681030     History of Changes
Other Study ID Numbers: 400-12-002
First Submitted: September 5, 2012
First Posted: September 7, 2012
Last Update Posted: September 18, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Cardiovascular Diseases
Thrombin
Fibrin Tissue Adhesive
Hemostatics
Coagulants