NCT00161902CompletedPhase 3
A Randomized, Controlled, Multicenter Study to Evaluate Efficacy and Safety of Fibrin Sealant VH S/D for Hemostasis in Subjects Undergoing Total Hip Replacement
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Locations
- 14
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Study Sites (14)
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