Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty
Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty
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.
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