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: September 9, 2014
Last verified: September 2014

September 5, 2012
September 9, 2014
August 2012
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01681030 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Fibrin Pad Cardiovascular Study
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cardiovascular Disease
  • 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).
  • Biological: Topical hemostat
    Equine collagen with Human Fibrinogen and Human Thrombin
  • 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.
  • 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).
    Intervention: Biological: EVARREST™
  • Active Comparator: Topical hemostat
    Equine collagen with Human Fibrinogen and Human Thrombin
    Intervention: Biological: Topical hemostat
  • 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.
    Intervention: Other: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
September 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01681030
400-12-002
Yes
Ethicon, Inc.
Ethicon, Inc.
Not Provided
Study Director: Jerome Riebman, MD Ethicon, Inc.
Ethicon, Inc.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP