Clinical trial NCT00161902: Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Hemostasis in Subjects Undergoing Total Hip Replacement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Replacement Surgery
Keywords: Arthroplasty
Hip Prosthesis
Cement Free Hip Prosthesis
Femur Head Necrosis
Coxarthrosis
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-13
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Krems
country: Austria
facility: A. ö. Krankenhaus Krems, Abteilung f. Orthopädie
state: Niederösterreich
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien, University Clinic for Orthopedics
city: Vienna
country: Austria
facility: Donauspital im SMZ Ost, Department of Orthopedic Surgery
city: Augsburg
country: Germany
facility: Klinik für Unfall- u. Wiederherstellungschirurgie des Zentralklinikums Augsburg
city: Geldrop
country: Netherlands
facility: St. Anna Ziekenhuis, Orthopedic Surgery
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht, Orthopedic Surgery
city: Rotterdam
country: Netherlands
facility: St. Clara Ziekenhuis, Orthopedic Surgery
Study officials:
affiliation: A. ö. Krankenhaus Krems, Austria
name: Florian Gottsauner-Wolf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Unfall- und Wiederherstellungschirurgie des Zentralklinikums Augsburg, Germany
name: Axel Rüter, MD
role: PRINCIPAL_INVESTIGATOR
References: