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

Phase 3

Completed

• Conditions: Hip Replacement Surgery

• Registration Number: NCT00161902
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08
• Study Completion: 2003-03
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-13
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-20
• Last Update Posted: 2006-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (7)

Academisch Ziekenhuis Maastricht, Orthopedic Surgery; 🇳🇱 Maastricht, Netherlands

St. Anna Ziekenhuis, Orthopedic Surgery; 🇳🇱 Geldrop, Netherlands

St. Clara Ziekenhuis, Orthopedic Surgery; 🇳🇱 Rotterdam, Netherlands

Klinik für Unfall- u. Wiederherstellungschirurgie des Zentralklinikums Augsburg; 🇩🇪 Augsburg, Germany

Allgemeines Krankenhaus der Stadt Wien, University Clinic for Orthopedics; 🇦🇹 Vienna, Austria

A. ö. Krankenhaus Krems, Abteilung f. Orthopädie; 🇦🇹 Krems, Niederösterreich, Austria

Donauspital im SMZ Ost, Department of Orthopedic Surgery; 🇦🇹 Vienna, Austria