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The Fibrin Pad Cardiovascular Study

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ClinicalTrials.gov Identifier: NCT01681030
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : March 7, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Biological: EVARREST™ Biological: Topical hemostat Other: Standard of Care Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Actual Study Start Date : August 1, 2012
Actual Primary Completion Date : August 1, 2013
Actual Study Completion Date : September 3, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. [ Time Frame: Intraoperative, 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


Secondary Outcome Measures :
  1. Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application [ Time Frame: Intraoperative, 6 minutes following treatment application ]
    The number of subjects achieving hemostatic success at 6 minutes following treatment application.

  2. Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application [ Time Frame: Intraoperative, 10 minutes following treatment application ]
    Number of subjects achieving hemostatic success at 10 minutes following treatment application.

  3. Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment [ Time Frame: Intra-operative, prior initiation of final chest wall closure. Safety Issue: ]
    The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had re-bleeding requiring treatment

  4. Number of Participants With Adverse Events Potentially Related to Thrombotic Events [ Time Frame: 30 days (+ 14 days) following surgery ]
    The number of subjects with an adverse event potentially related to a thrombotic event



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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
Indianapolis, 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.

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01681030     History of Changes
Other Study ID Numbers: 400-12-002
First Posted: September 7, 2012    Key Record Dates
Results First Posted: March 7, 2018
Last Update Posted: June 12, 2018
Last Verified: May 2018

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