Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures

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

Official Title
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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

Conditions
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Peripheral Vascular Disease

Intervention / Treatment
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* Drug: Fibrin sealant (FS2)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fibrin sealant (FS2)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attainment of hemostasis at following randomization. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attainment of hemostasis following randomization. |  |  | 
| Incidence of treatment failures |  |  | 
| Incidence of potential bleeding-related complications |  |  | 
| Adverse events |  |  |