Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154141

Enrollment

150

Registered

2005-09-12

Start date

2005-06-30

Completion date

2006-03-31

Last updated

2006-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Vascular Disease

Brief summary

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

Interventions

DRUGFibrin sealant (FS2)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Attainment of hemostasis at following randomization.	—

Secondary

Measure	Time frame
Attainment of hemostasis following randomization.	—
Incidence of treatment failures	—
Incidence of potential bleeding-related complications	—
Adverse events	—

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026