Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures

July 11, 2006 updated by: Ethicon, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Memorial Hospital
      • Jacksonville, Florida, United States, 32216
        • Baptist Medical Center
      • Miami, Florida, United States, 33103
        • Jackson Memorial Hospital
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Iowa Heart Center
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Univ of Mass Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Alband Medical Center
      • Buffalo, New York, United States, 14209
        • Millarad Fillmore Hospital, SUNY
    • Ohio
      • Toledo, Ohio, United States, 43606
        • Jobst Vascular Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Univ Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • UVA Health System
      • Norfolk, Virginia, United States, 23503
        • Vascular and Transplant Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Attainment of hemostasis at following randomization.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon, Inc.

Collaborators

OMRIX Biopharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

July 13, 2006

Last Update Submitted That Met QC Criteria

July 11, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 400-05-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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