A randomized, single-blind, parallel-group, multi-center comparative study to assess the efficacy and safety of an application of Fybex (fibrin sealant) to the operative field, for the reduction of post-operative blood loss, when added to standard intra-operative hemostatic procedures and compared to standard intra-operative hemostatic procedures alone, in adult patients undergoing total hip arthroplasty - A study to assess the effect of Fybex fibrin sealant on post-operative blood loss, given during hip
- Conditions
- Total hip arthroplasty
- Registration Number
- EUCTR2005-001228-35-GB
- Lead Sponsor
- Bio Products Laboratory
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
·Patients undergoing total hip replacement·Age > 18 years·Able to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
·History of bleeding disorders·Hb < 110g/L·Previous hip surgery·Use of other blood products within 3 months·Positive for HBsAg, HCV or HIV
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the efficacy of Fybex in reducing post-operative blood loss in patients undergoing total hip arthroplasty.;Secondary Objective: To investigate the hemostatic effect and safety, including local tolerance and viral safety, of Fybex in patients undergoing total hip arthroplasty;Primary end point(s): Post-operative blood loss.
- Secondary Outcome Measures
Name Time Method