Analysis of Blood Loss With the Use of Fibrin Sealant in Total Knee Replacement Surgery – A Randomised Controlled Study - RCT evaluating effects of fibrin sealant on blood loss in TKR ver 001

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011492-73-GB

Enrollment

Registered

2009-06-12

Start date

2009-09-28

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Blood loss in total knee arthroplasty

Interventions

Trade Name: Evicel Product Name: Evicel Pharmaceutical Form: Sealant INN or Proposed INN: Fibrinogen Concentration unit: mg milligram(s) Concentration type: range Concentration number: 250-450 INN or

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Subjects must be willing to participate in the study, and provide written informed consent. 2. Subjects scheduled to undergo primary, unilateral, cemented total knee replacement for a diagnosis of primary osteoarthritis. 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: Exclusion criteria 1. Subjects who have had previous surgery to the knee (with exception of arthroscopic procedures); 2. Subjects with a recognised bleeding diasthesis; 3. Subjects with platelet or bone-marrow disorders; 4. Subjects undergoing or potentially requiring warfarin or other anticoagulation therapy (including those with a history of thrombotic or thromboembolic events in whom additional post-operative thromboprophylaxis would be required); 5. Subjects undergoing uncemented knee replacements; 6. Subjects undergoing bilateral total knee replacement surgery. 7. Subjects with recognised immunocompromise, and those with a history of severe or anaphylactic reaction to human blood products.

Design outcomes

Primary

Measure	Time frame
Main Objective: Does the use of a fibrin sealant in addition to existing methods to control bleeding reduce postoperative blood loss?;Secondary Objective: Should blood loss be lessened: Does this reduce the need for blood transfusion? Is a more rapid return to function obtained? Is post-operative swelling less? Is pain reduced? Is length of hospital stay decreased? Are there any complications associated with the use of fibrin sealant?;Primary end point(s): Calculated total blood loss in each group	—

Measure

Time frame

Main Objective: Does the use of a fibrin sealant in addition to existing methods to control bleeding reduce postoperative blood loss?;Secondary Objective: Should blood loss be lessened: Does this reduce the need for blood transfusion? Is a more rapid return to function obtained? Is post-operative swelling less? Is pain reduced? Is length of hospital stay decreased? Are there any complications associated with the use of fibrin sealant?;Primary end point(s): Calculated total blood loss in each group

—

Countries

United Kingdom

Outcome results

None listed

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