Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures

Completed · Phase 3

Conditions studied: Peripheral Vascular Disease

In brief

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

Key facts

Study ID

NCT00154141

Run by

Ethicon, Inc.

People needed

150

Starts

2005-06-01

Expected to finish

2006-03-01

Last updated by the study team

2006-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Baptist Medical Center — Jacksonville, Florida, United States
• Memorial Hospital — Jacksonville, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Iowa Heart Center — Des Moines, Iowa, United States
• Univ of Mass Medical Center — Worcester, Massachusetts, United States
• Hackensack Medical Center — Hackensack, New Jersey, United States
• Alband Medical Center — Albany, New York, United States
• Millarad Fillmore Hospital, SUNY — Buffalo, New York, United States
• Jobst Vascular Center — Toledo, Ohio, United States
• Vanderbilt Univ Medical Center — Nashville, Tennessee, United States
• UVA Health System — Charlottesville, Virginia, United States
• Vascular and Transplant Specialists — Norfolk, Virginia, United States
• Aberdeen Royal Infirmary — Aberdeen, United Kingdom
• Birmingham Heartlands Hospital — Birmingham, United Kingdom
• Royal Infirmary of Edinburgh — Edinburgh, United Kingdom
• Hull Royal Infirmary — Hull, United Kingdom

Full record on ClinicalTrials.gov

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