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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001228-35-GB
Enrollment
90
Registered
2005-09-19
Start date
2005-11-23
Completion date
Unknown
Last updated
2012-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total hip arthroplasty

Interventions

Product Name: FYBEX Product Code: Fibrin Sealant Pharmaceutical Form: Powder and solvent for sealant

Sponsors

Bio Products Laboratory
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026