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

Hip Replacement Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161902
• Other study ID #: 550001
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: October 20, 2006
• Start date: August 2001
• Est. completion date: March 2003

Study information

• Verified date: October 2006
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2003
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Replacement Surgery

Intervention

Drug:
• Fibrin Sealant Vapor-Heated Solvent/Detergent-treated

Locations

Country	Name	City	State
Austria	A. ö. Krankenhaus Krems, Abteilung f. Orthopädie	Krems	Niederösterreich
Austria	Allgemeines Krankenhaus der Stadt Wien, University Clinic for Orthopedics	Vienna
Austria	Donauspital im SMZ Ost, Department of Orthopedic Surgery	Vienna
Germany	Klinik für Unfall- u. Wiederherstellungschirurgie des Zentralklinikums Augsburg	Augsburg
Netherlands	St. Anna Ziekenhuis, Orthopedic Surgery	Geldrop
Netherlands	Academisch Ziekenhuis Maastricht, Orthopedic Surgery	Maastricht
Netherlands	St. Clara Ziekenhuis, Orthopedic Surgery	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands,