Status:
COMPLETED
Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Hemostasis in Subjects Undergoing Total Hip Replacement
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Hip Replacement Surgery
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
End Date :
March 1 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00161902
Start Date
August 1 2001
End Date
March 1 2003
Last Update
October 23 2006
Active Locations (7)
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1
A. ö. Krankenhaus Krems, Abteilung f. Orthopädie
Krems, Lower Austria, Austria, 3500
2
Allgemeines Krankenhaus der Stadt Wien, University Clinic for Orthopedics
Vienna, Austria, 1090
3
Donauspital im SMZ Ost, Department of Orthopedic Surgery
Vienna, Austria, 1220
4
Klinik für Unfall- u. Wiederherstellungschirurgie des Zentralklinikums Augsburg
Augsburg, Germany, 86156