Safety of intravenous tranexamic acid in patients undergoing majororthopaedic surgery: a meta-analysis of randomised controlled trials

Abstract

Among the various pharmacological options to decrease peri-operative bleeding, tranexamic acid appears to be one of the most interesting. Several trials have consistently documented the efficacy of this synthetic drug in reducing the risk of blood loss and the need for allogeneic blood transfusion in patients undergoing total hip and knee arthroplasty. The safety of intravenous tranexamic acid in major orthopaedic surgery, particularly regarding the risk of venous thromboembolism, was systematically analysed in this review. A systematic search of the literature identified 73 randomised controlled trials involving 4,174 patients and 2,779 controls. The raw overall incidence of venous thromboembolism was 2.1% in patients who received intravenous tranexamic acid and 2.0% in controls. A meta-analytic pooling showed that the risk of venous thromboembolism in tranexamic acid-treated patients was not significantly different from that of controls (risk difference: 0.01%, 95% confidence interval [CI]: -0.05%, 0.07%; risk ratio: 1.067, 95% CI: 0.760-1.496). Other severe drug-related adverse events occurred very rarely (0.1%). In conclusion, the results of this systematic review and meta-analysis show that intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopaedic surgery.

Conflict of interest statement

Disclosure of conflicts of interest

GML is the Editor-in-Chief of Blood Transfusion and this manuscript has undergone additional external review as a result. The other Authors declare no conflicts of interest.

Figures

Figure 1

Flow chart of the inclusion of the studies. RCTs: randomised controlled trials.

Figure 2A

Effect of tranexamic acid on VTE risk: meta-analytical pooling. The effect was comparatively measured as risk difference (Figure 2A) and risk ratio (Figure 2B). Squares denote the risk difference and risk ratio, with their size being proportional to the weight assigned to the study. Horizontal bars indicate the 95% CI for each study. The diamonds represent the aggregate effect, with their width representing the 95% CI of the total effect. CI: confidence interval; RD: risk difference; TXA: tranexamic acid; VTE: venous thromboembolism.

Figure 2B

Effect of tranexamic acid on VTE risk: meta-analytical pooling. The effect was comparatively measured as risk difference (Figure 2A) and risk ratio (Figure 2B). Squares denote the risk difference and risk ratio, with their size being proportional to the weight assigned to the study. Horizontal bars indicate the 95% CI for each study. The diamonds represent the aggregate effect, with their width representing the 95% CI of the total effect. CI: confidence interval; RR: risk ratio; TXA: tranexamic acid; VTE: venous thromboembolism.