Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures
Phase 3
Completed
- Conditions
- Peripheral Vascular Disease
- Registration Number
- NCT00154141
- Lead Sponsor
- Ethicon, Inc.
- Brief Summary
A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Attainment of hemostasis at following randomization.
- Secondary Outcome Measures
Name Time Method Attainment of hemostasis following randomization. Incidence of treatment failures Incidence of potential bleeding-related complications Adverse events
Trial Locations
- Locations (17)
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
Scroll for more (7 remaining)Baptist Medical Center🇺🇸Jacksonville, Florida, United States