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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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00161902
First received: September 8, 2005
Last updated: October 20, 2006
Last verified: October 2006
  Purpose

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

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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Study Start Date: August 2001
Estimated Study Completion Date: March 2003
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161902

Locations
Austria
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
Germany
Klinik für Unfall- u. Wiederherstellungschirurgie des Zentralklinikums Augsburg
Augsburg, Germany, 86156
Netherlands
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
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00161902     History of Changes
Other Study ID Numbers: 550001
Study First Received: September 8, 2005
Last Updated: October 20, 2006
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Baxter Healthcare Corporation:
Arthroplasty
Hip Prosthesis
Cement Free Hip Prosthesis
Femur Head Necrosis
Coxarthrosis

Additional relevant MeSH terms:
Fibrin Tissue Adhesive
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014