Comparação entre duas doses de ácido tranexâmico intra‐articular no sangramento pós‐operatório de artroplastia total do joelho: estudo clínico randomizado

Abstract

Introduction

Tranexamic Acid (TXA), an antifibrinolytic that inhibits the fibrinolytic activity of plasmin is used to decrease perioperative blood loss and transfusion requirements in orthopedic surgery. The aim of our study was to compare postoperative bleeding in two intra‐articular doses (1 g and 2 g) of tranexamic acid in adult patients undergoing unilateral total knee replacement.

Method

We conducted a single‐operator, randomized, and controlled, double‐blind study in two groups. The G1 group received 1 g of intra‐articular TXA and the G2 group 2 g of intra‐articular TXA. Both groups received 15 mg.kg^‐1 IV before the surgical incision (TXA induction dose) and then 10 mg.kg^‐1, orally, 6 and 12 hours after the induction dose of TXA. The primary endpoint was bleeding measured by blood loss in postoperative drainage. Secondary outcomes were change in hemoglobin and hematocrit levels on the first and third postoperative days, and the need for transfusion during hospitalization.

Results

In total, 100 patients were randomized, and 100 were included in the analysis. Blood loss in postoperative drainage was similar in both groups (200 ± 50 vs. 250 ± 50 mL, G1 and G2 groups respectively). Change in hematocrit and hemoglobin values (% of change) between preoperative and day 3 were not statically significant between groups G1 and G2 (18 ± 5 vs. 21 ± 4; 21 ± 7 vs. 22 ± 5 respectively). No patients received blood transfusion.

Conclusions

Our study did not show superiority of 2 g of intra‐articular tranexamic acid compared to 1 g.

ClinicalTrials.gov Identifier NCT04085575