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A randomized, sigle-blind, parallel group, multicentre 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 knee arthroplasty - A study to assess the effect of Fybex fibrin sealant on post-operative blood loss, given during knee

A randomized, sigle-blind, parallel group, multicentre 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 knee arthroplasty - A study to assess the effect of Fybex fibrin sealant on post-operative blood loss, given during knee

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001229-27-GB
Enrollment
96
Registered
2005-09-26
Start date
2005-11-23
Completion date
Unknown
Last updated
2019-11-25

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

Conditions

Total knee arthroplasty

Interventions

Product Name: Fybex Pharmaceutical Form: Powder and solvent for sealant

Sponsors

Bio Products Laboratory
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients undergoing total knee replacement over 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 under 110g/L previous knee 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 knee arthroplasty;Secondary Objective: To investigate the hemostatic effect and safety, including local tolerance and viral safety, of Fybex in patients undergoing total knee 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