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Fibrin Sealant Vascular Surgery Study
This study is ongoing, but not recruiting participants.
Sponsored by: Baxter Healthcare Corporation
Information provided by: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00576420
  Purpose

The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in subjects receiving prosthetic expanded polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual compression with surgical gauze pads.


Condition Intervention Phase
Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)
Drug: FS VH S/D 500 s-apr , 60 seconds polymerization time
Drug: FS VH S/D 500 s-apr , 120 seconds polymerization time
Procedure: Manual compression with surgical gauze pads
Phase II
Phase III

Drug Information available for: Fibrin Beriplast
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 s-Apr for Hemostasis in Subjects Undergoing Vascular Surgery

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • The primary endpoint of this study will be the proportion of subjects achieving hemostasis at the study suture line at 4 minutes. Hemostasis must be maintained until closure of the surgical wound. [ Time Frame: 4 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects having achieved hemostasis at 6 minutes which is maintained until closure of the surgical wound [ Time Frame: 6 minutes ] [ Designated as safety issue: No ]
  • The proportion of subjects having achieved hemostasis at 10 minutes, which is maintained until closure of the surgical wound [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: December 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time
Drug: FS VH S/D 500 s-apr , 60 seconds polymerization time
FS VH S/D 500 s-apr is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.
2: Experimental
FS VH S/D 500 s-apr, 120 seconds polymerization time
Drug: FS VH S/D 500 s-apr , 120 seconds polymerization time
Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.
3
Treatment of the study-suture line will be manual compression with surgical gauze pads.
Procedure: Manual compression with surgical gauze pads
Treatment of the study-suture line will be manual compression with surgical gauze pads.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female of all ages
  • Subject undergoing peripheral vascular surgery, conduit placement with an ePTFE graft such as arterio-arterial bypasses including: axillo-femoral, ilio-femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass, arteriovenous dialysis access shunt in the upper or lower extremity.
  • Signed informed consent

Intraoperative inclusion criterion:

- Suture line bleeding eligible for study treatment is present after surgical hemostasis (i.e., suturing).

Suture line bleeding eligible for study treatment is defined as: any suture line bleeding that would prevent immediate closure of the wound and require treatment of the bleeding first, and on a scale of mild, moderate, and severe, the suture line bleeding is assessed as moderate or severe. (Moderate is defined as: either more than 25% of the suture line bleeds, or at least 5 suture line bleedings are present, if counting of suture line bleedings is possible, or one pulsatile suture line bleeding is present. Severe is defined as: either more than 50% of the suture line bleeds, or at least 10 suture line bleedings present, if counting of suture line bleedings is possible, or more than one pulsatile suture line bleedings are present, or at least one spurting suture line bleeding is present.)

Note: Bleedings that can be treated with additional sutures are not appropriate for the study. Such anastomoses should receive additional sutures, be re-categorized, and if they still comply with the inclusion criteria, be randomized.

Exclusion Criteria:

  • Subjects concurrently participating in another clinical study treatment with another investigational drug or device within the last 30 days
  • Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
  • Arterio-arterial bypasses with more than 2 anastomoses (e.g., aorto-bifemoral, axillo-bifemoral etc.)
  • Pregnant or lactating women
  • Congenital coagulation disorders
  • Prior kidney transplantation
  • Heparin-induced thrombocytopenia
  • Known prior exposure to aprotinin within the last 12 months
  • Known hypersensitivity to aprotinin or other components of the product
  • Known severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs)
  • Prior radiation therapy to the operating field
  • Severe local inflammation at the operating field.

Intraoperative exclusion criterion:

  • Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
  • Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria, (e.g. abandonment of ePTFE graft placement).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576420

Locations
United States, Alabama
Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, United States, 35235
United States, Arizona
Arizona Endovascular Center
Tucson, Arizona, United States, 85710
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Long Beach VA Healthcare System
Long Beach, California, United States, 90822
United States, Florida
Baptist Medical Center, Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Health First Clinical Research Institute
Melbourne, Florida, United States, 32901
Memorial Hospital Jacksonville, Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
United States, Illinois
University of Chicago, Department of Surgery, J-555
Chicago, Illinois, United States, 60637
United States, Kentucky
University of Kentucky Department of Surgery, Division of Cardiovascular and Thoracic Surgery
Lexington, Kentucky, United States, 40536-0200
United States, Louisiana
Vascular Surgery Associates of Baton Rouge, Clinical research Division
Baton Rouge, Louisiana, United States, 70809-3675
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Utah
University of Utah Department of Surgery
Salt Lake City, Utah, United States, 84132
United States, Virginia
Surgical Therapeutic Advancement Center, University of Virginia
Charlottesville, Virginia, United States, 22908
Vascular and Transplant Specialists
Virginia Beach, Virginia, United States, 23452
United States, Washington
Harbor View Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Baxter Healthcare Corporation
  More Information

Responsible Party: Baxter Healthcare Corporation ( Edward J. Kim, Clinical Project Manager )
Study ID Numbers: 550602
Study First Received: December 18, 2007
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00576420  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Fibrin Tissue Adhesive

ClinicalTrials.gov processed this record on January 16, 2009