Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Hemostasis in Subjects Undergoing Total Hip Replacement

October 20, 2006 updated by: Baxter Healthcare Corporation

A Randomized, Controlled, Multicenter Study to Evaluate Efficacy and Safety of Fibrin Sealant VH S/D for Hemostasis in Subjects Undergoing Total Hip Replacement

The purpose of the study is to monitor the safety of FS VH S/D and evaluate whether FS VH S/D is superior to standard treatment in reducing blood loss in subjects undergoing total hip replacement with cement-free hip prostheses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • Austria
      • Vienna, Austria, 1090
        • Allgemeines Krankenhaus der Stadt Wien, University Clinic for Orthopedics
      • Vienna, Austria, 1220
        • Donauspital im SMZ Ost, Department of Orthopedic Surgery
    • Niederösterreich
      • Krems, Niederösterreich, Austria, 3500
        • A. ö. Krankenhaus Krems, Abteilung f. Orthopädie
  • Germany
      • Augsburg, Germany, 86156
        • Klinik für Unfall- u. Wiederherstellungschirurgie des Zentralklinikums Augsburg
  • Netherlands
      • Geldrop, Netherlands, 5664
        • St. Anna Ziekenhuis, Orthopedic Surgery
      • Maastricht, Netherlands, 6229
        • Academisch Ziekenhuis Maastricht, Orthopedic Surgery
      • Rotterdam, Netherlands, 3078
        • St. Clara Ziekenhuis, Orthopedic Surgery

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

Each subject to be included into the study must fulfill the following inclusion criteria:

  • Subjects receiving a cement free hip prosthesis due to coxarthrosis because of primary or dysplastic arthrosis grade 1 - 3 according to Crowe or rheumatoid arthritis as well as subjects receiving a cement free hip prosthesis due to femur head necrosis (Crowe classification).
  • ASA and NSAIDs have been discontinued one week prior to surgery
  • Written informed consent
  • Male and female at least 19 years of age

Exclusion Criteria:

Subjects fulfilling the following exclusion criteria will not be recruited into the study:

  • Impaired coagulation
  • Previous hip surgery
  • Acetabular roof plastic
  • Known hypersensitivity to aprotinin or other components of the product
  • Immunodeficiency
  • Increased red cell production
  • Pregnant or lactating women (positive urine or serum pregnancy test; this test is required of any female subject who is not post menopausal or surgically sterilized).
  • Subjects concurrently participating in another clinical trial or having received another investigational drug within the last 30 days.

Also patients with abnormal coagulation values due to anticoagulants like coumadins or heparin must be excluded.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Collaborators and Investigators

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

Sponsor

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: Florian Gottsauner-Wolf, MD, A. ö. Krankenhaus Krems, Austria
  • Principal Investigator: Axel Rüter, MD, Klinik für Unfall- und Wiederherstellungschirurgie des Zentralklinikums Augsburg, Germany

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

August 1, 2001

Study Completion

March 1, 2003

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

October 23, 2006

Last Update Submitted That Met QC Criteria

October 20, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 550001

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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