Hip Replacement Surgery Clinical Trial
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
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | March 2003 |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | A. ö. Krankenhaus Krems, Abteilung f. Orthopädie | Krems | Niederösterreich |
Austria | Allgemeines Krankenhaus der Stadt Wien, University Clinic for Orthopedics | Vienna | |
Austria | Donauspital im SMZ Ost, Department of Orthopedic Surgery | Vienna | |
Germany | Klinik für Unfall- u. Wiederherstellungschirurgie des Zentralklinikums Augsburg | Augsburg | |
Netherlands | St. Anna Ziekenhuis, Orthopedic Surgery | Geldrop | |
Netherlands | Academisch Ziekenhuis Maastricht, Orthopedic Surgery | Maastricht | |
Netherlands | St. Clara Ziekenhuis, Orthopedic Surgery | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Baxter Healthcare Corporation |
Austria, Germany, Netherlands,
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---|---|---|---|
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