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

NCT ID: NCT00161902

Last Updated: 2006-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2003-03-31

Brief Summary

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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

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Conditions

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Hip Replacement Surgery

Keywords

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Arthroplasty Hip Prosthesis Cement Free Hip Prosthesis Femur Head Necrosis Coxarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Fibrin Sealant Vapor-Heated Solvent/Detergent-treated

Intervention Type DRUG

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

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Florian Gottsauner-Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

A. ö. Krankenhaus Krems, Austria

Axel Rüter, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Unfall- und Wiederherstellungschirurgie des Zentralklinikums Augsburg, Germany

Locations

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A. ö. Krankenhaus Krems, Abteilung f. Orthopädie

Krems, Lower Austria, Austria

Site Status

Allgemeines Krankenhaus der Stadt Wien, University Clinic for Orthopedics

Vienna, , Austria

Site Status

Donauspital im SMZ Ost, Department of Orthopedic Surgery

Vienna, , Austria

Site Status

Klinik für Unfall- u. Wiederherstellungschirurgie des Zentralklinikums Augsburg

Augsburg, , Germany

Site Status

St. Anna Ziekenhuis, Orthopedic Surgery

Geldrop, , Netherlands

Site Status

Academisch Ziekenhuis Maastricht, Orthopedic Surgery

Maastricht, , Netherlands

Site Status

St. Clara Ziekenhuis, Orthopedic Surgery

Rotterdam, , Netherlands

Site Status

Countries

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Austria Germany Netherlands

Other Identifiers

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550001

Identifier Type: -

Identifier Source: org_study_id