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

Baxter

Status and phase

Completed

Phase 3

Conditions

Hip Replacement Surgery

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00161902

550001

Details and patient eligibility

About

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.

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.