Comparison of two doses of intra-articular tranexamic acid on postoperative bleeding in total knee arthroplasty: a randomized clinical trial
Comparação entre duas doses de ácido tranexâmico intra-articular no sangramento pós-operatório de artroplastia total do joelho: estudo clínico randomizado
Edmundo Pereira de Souza Neto, Gorka Usandizaga
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
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
Keywords
Resumo
Introdução
O Ácido Tranexâmico (TXA), agente antifibrinolítico que inibe a atividade fibrinolítica da plasmina, é usado para reduzir a perda sanguínea perioperatória e a necessidade de transfusão em cirurgia ortopédica. O objetivo do estudo foi comparar o efeito de duas doses intra-articulares (1 g e 2 g) de ácido tranexâmico no sangramento pós-operatório de pacientes adultos submetidos à prótese total unilateral de joelho.
Método
Realizamos estudo com operador único, randomizado, controlado e duplo-cego em dois grupos. O grupo G1 recebeu 1 g de TXA intra-articular e o grupo G2, 2 g de TXA intra-articular. Os dois grupos receberam 15 mg.kg-1 IV antes da incisão cirúrgica (dose de indução de TXA) e 10 mg.kg-1 por via oral, 6 e 12 horas após a dose de indução de TXA. O desfecho primário foi o sangramento medido pela perda sanguínea na drenagem pós-operatória. Os desfechos secundários foram alteração nos níveis de hemoglobina e hematócrito no primeiro e terceiro dias de pós-operatório e necessidade de transfusão durante a hospitalização.
Resultados
A perda sanguínea pela drenagem pós-operatória foi semelhante nos dois grupos (200 ± 50 mL vs. 250 ± 50 mL, grupos G1 e G2, respectivamente). A variação nos valores de hematócrito e hemoglobina (% de variação) entre o pré-operatório e o dia 3 não foi estatisticamente significante entre os grupos G1 e G2 (18 ± 5 vs. 21 ± 4; 21 ± 7 vs. 22 ± 5, respectivamente). Nenhum paciente recebeu transfusão de sangue.
Conclusões
O estudo não mostrou superioridade na dose de 2 g de ácido tranexâmico intra-articular em comparação à dose de 1 g.
Palavras-chave
References
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