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Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures

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. Identifier: NCT00154141
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 13, 2006
OMRIX Biopharmaceuticals
Information provided by:
Ethicon, Inc.

Brief Summary:
A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Drug: Fibrin sealant (FS2) Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: A Prospective, Randomized Controlled Study to Compare the Effects of a Fibrin Sealant (FS2) Versus Manual Compression on Haemostatic Efficacy During Vascular Surgical Procedures Utilising Polytetrafluorethylene Graft Material on an End-to-Side Femoral or Upper Extremity Vascular Access Arterial Anastomosis
Study Start Date : June 2005
Study Completion Date : March 2006

Primary Outcome Measures :
  1. Attainment of hemostasis at following randomization.

Secondary Outcome Measures :
  1. Attainment of hemostasis following randomization.
  2. Incidence of treatment failures
  3. Incidence of potential bleeding-related complications
  4. Adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side femoral or upper extremity vascular access arterial anastomosis (e.g. femoral-femoral, femoral-popliteal, femoral-tibial, ilio-femoral, aorto-bifemoral, abdominal aortic aneurysm, upper extremity vascular access for dialysis) using uncoated or heparin-coated PTFE grafts and polypropylene sutures (size 5-0 or 6-0) with a 1:1 needle-to-thread ratio.
  • Following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the SAS.
  • Subjects must be willing to and capable of participating in the study, and provided written informed consent.

Exclusion Criteria:

  • Subjects undergoing re-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than uncoated or heparin-coated PTFE.
  • Subjects undergoing emergency surgery.
  • Subjects with any intra-operative findings that may preclude conduct of the study procedure.
  • Subjects with known intolerance to heparin, blood products or to one of the components of the study product.
  • Subjects unwilling to receive blood products.
  • Subjects with autoimmune immunodeficiency diseases (including known HIV).
  • Subjects who are known, current alcohol and / or drug abusers.
  • Subjects who have participated in another investigational drug or device research study within 30 days of enrolment.
  • 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 identifier (NCT number): NCT00154141

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Sponsors and Collaborators
Ethicon, Inc.
OMRIX Biopharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00154141    
Other Study ID Numbers: 400-05-001
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 13, 2006
Last Verified: July 2006
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases
Fibrin Tissue Adhesive