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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00161902 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Each subject to be included into the study must fulfill the following inclusion criteria:
Exclusion Criteria:
Subjects fulfilling the following exclusion criteria will not be recruited into the study:
Also patients with abnormal coagulation values due to anticoagulants like coumadins or heparin must be excluded.
Austria | |
Donauspital im SMZ Ost, Department of Orthopedic Surgery | |
Vienna, Austria, 1220 | |
Allgemeines Krankenhaus der Stadt Wien, University Clinic for Orthopedics | |
Vienna, Austria, 1090 | |
Austria, Niederösterreich | |
A. ö. Krankenhaus Krems, Abteilung f. Orthopädie | |
Krems, Niederösterreich, Austria, 3500 | |
Germany | |
Klinik für Unfall- u. Wiederherstellungschirurgie des Zentralklinikums Augsburg | |
Augsburg, Germany, 86156 | |
Netherlands | |
Academisch Ziekenhuis Maastricht, Orthopedic Surgery | |
Maastricht, Netherlands, 6229 | |
St. Anna Ziekenhuis, Orthopedic Surgery | |
Geldrop, Netherlands, 5664 | |
St. Clara Ziekenhuis, Orthopedic Surgery | |
Rotterdam, Netherlands, 3078 |
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 ID Numbers: | 550001 |
Study First Received: | September 8, 2005 |
Last Updated: | October 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00161902 |
Health Authority: | Austria: Federal Ministry for Health and Women |
Arthroplasty Hip Prosthesis Cement Free Hip Prosthesis Femur Head Necrosis Coxarthrosis |
Necrosis Fibrin Tissue Adhesive Femur Head Necrosis Osteoarthritis, Hip |
Coagulants Therapeutic Uses Hematologic Agents Pharmacologic Actions Hemostatics |