Status:
COMPLETED
Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures
Lead Sponsor:
Ethicon, Inc.
Collaborating Sponsors:
OMRIX Biopharmaceuticals
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00154141
Start Date
June 1 2005
End Date
March 1 2006
Last Update
July 13 2006
Active Locations (17)
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1
Baptist Medical Center
Jacksonville, Florida, United States, 32216
2
Memorial Hospital
Jacksonville, Florida, United States, 32216
3
Jackson Memorial Hospital
Miami, Florida, United States, 33103
4
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702