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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00161902
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : October 23, 2006
Information provided by:
Baxter Healthcare Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hip Replacement Surgery Drug: Fibrin Sealant Vapor-Heated Solvent/Detergent-treated Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Multicenter Study to Evaluate Efficacy and Safety of Fibrin Sealant VH S/D for Hemostasis in Subjects Undergoing Total Hip Replacement
Study Start Date : August 2001
Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00161902

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

Layout table for additonal information Identifier: NCT00161902     History of Changes
Other Study ID Numbers: 550001
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: October 23, 2006
Last Verified: October 2006
Keywords provided by Baxter Healthcare Corporation:
Hip Prosthesis
Cement Free Hip Prosthesis
Femur Head Necrosis
Additional relevant MeSH terms:
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Fibrin Tissue Adhesive