Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures

Peripheral Vascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154141
• Other study ID #: 400-05-001
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: July 11, 2006
• Start date: June 2005
• Est. completion date: March 2006

Study information

• Verified date: July 2006
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• Fibrin sealant (FS2)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Ethicon, Inc.	OMRIX Biopharmaceuticals

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attainment of hemostasis at following randomization.
Secondary	Attainment of hemostasis following randomization.
Secondary	Incidence of treatment failures
Secondary	Incidence of potential bleeding-related complications
Secondary	Adverse events