Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives:

a) Principal: To assess if the fibrin glue or the tranexamic acid reduce less than 20% the blood losses with respect to the habitual haemostasia in patients with arthroplasty total of knee.

Secondaries: To assess the treatment safety. To perform a cost- analyses.

Methods: Randomized, unicentric, and parallel clinical trial with four comparative groups:

Tissucol® (fibrin glue), fibrin glue manufactured by the Cryoseal® system (Banc de Sang i Teixits de Catalunya), tranexamic acid and habitual haemostasia.

Nº of participant centres: 1. Random allocation will be centralised.

Main outcome: Blood losses (ml) in the post-operatory period collected by the habitual drain system.

Secondary outcomes: Proportion of patients with blood transfusion, complications of surgery wound, pre and post-operative haemoglobin, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.

Size sample calculation: The number needed of patients is 172 (43 per group) to demonstrate a 20% difference in the post-operative blood losses between the treatments assessed and the habitual haemostasia, with a statistical power of 80% and a 0.05 bilateral alpha, and a 20% of withdrawals.

Statistical analysis: The investigators will perform a comparison of outcomes through the "t" test, the Mann-Whitney test of chi square, depending of the evaluated outcomes, quantitative or ordinals or qualitative, respectively. The software used will be Statistical Package for the Social Sciences (SPSS) version 17.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborator: Banc de Sang i Teixits
• Treatments: Fibrin Tissue Adhesive; Hemostatics; Tranexamic Acid

Criteria

Inclusion Criteria:

• Total knee arthroplasty

• The patient consent to participate

Exclusion Criteria:

• Intolerance drugs to the study or to bovine protein (aprotinin)

• Antecedent of thromboembolic disease

• Patient with cardiac alterations of the rhythm

• Patients with valvular cardiac prosthesis

• Patients with pro-thrombotic alterations of coagulation

• Treatment with anticonceptive drugs