Knee Arthropathy Clinical Trial
Official title:
Prevention of Postoperative Blood Loss: Randomised Unicentric Parallel Clinical Trial That Assess the Efficacy of Fibrin Glue and Tranexamic Acid in Surgical Patients With a 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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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