Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ethicon, Inc.
• Collaborator: OMRIX Biopharmaceuticals
• Treatments: Fibrin Tissue Adhesive

Criteria

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.