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

NCT00161902 | Completed Phase 3

• 1 other identifier: 550001
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 7

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.

Conditions

Hip Replacement Surgery

Keywords

Arthroplasty; Hip Prosthesis; Cement Free Hip Prosthesis; Femur Head Necrosis; Coxarthrosis

Interventions

Fibrin Sealant Vapor-Heated Solvent/Detergent-treated DRUG

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (7)

A. ö. Krankenhaus Krems, Abteilung f. Orthopädie

Krems, Lower Austria, 3500, Austria

Location

Allgemeines Krankenhaus der Stadt Wien, University Clinic for Orthopedics

Vienna, 1090, Austria

Location

Donauspital im SMZ Ost, Department of Orthopedic Surgery

Vienna, 1220, Austria

Location

Klinik für Unfall- u. Wiederherstellungschirurgie des Zentralklinikums Augsburg

Augsburg, 86156, Germany

Location

St. Anna Ziekenhuis, Orthopedic Surgery

Geldrop, 5664, Netherlands

Location

Academisch Ziekenhuis Maastricht, Orthopedic Surgery

Maastricht, 6229, Netherlands

Location

St. Clara Ziekenhuis, Orthopedic Surgery

Rotterdam, 3078, Netherlands

Location

MeSH Terms

Conditions

Femur Head Necrosis; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Study Officials

• Florian Gottsauner-Wolf, MD

  A. ö. Krankenhaus Krems, Austria

  PRINCIPAL INVESTIGATOR

• Axel Rüter, MD

  Klinik für Unfall- und Wiederherstellungschirurgie des Zentralklinikums Augsburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 13, 2005
• Study Start: August 1, 2001
• Study Completion: March 1, 2003
• Last Updated: October 23, 2006

Record last verified: 2006-10

Locations

DE (1); NL (3); AU (3)