Role of tranexamic acid in craniosynostosis surgery: Systematic review and meta-analysis.

Abstract

This study aimed to determine the efficacy and harms of using tranexamic acid (TXA) versus placebo/no intervention to reduce blood loss and the need for transfusion in children undergoing surgical correction of craniosynostosis. We searched MEDLINE (OVID), EMBASE, LILACS, CENTRAL, and other sources. We included clinical trials, prospective, retrospective observational studies, case-control studies, and cohort studies. The primary outcomes were blood loss and the need for a transfusion, and secondary outcomes were hemoglobin, hematocrit, and adverse effects. We assessed the risk of bias with the Cochrane Collaboration tool. We performed the statistical analysis in R and reported information about the mean difference (MD) with a 95% confidence interval (CI). We evaluated heterogeneity with the I2 test. We produced forest plots to show the amount of evidence available for each outcome and made subgroup analyses. We included 11 studies in qualitative and quantitative analysis accounting for 752 patients. In general, the risk of all bias was assessed as low for non-randomized studies, and we found high performance and detection bias in one randomized study. TXA significantly reduced blood loss and need for transfusion compared to placebo/no intervention with an MD of -15.47 (95%CI -23.82, -7.11) and -8.18 (95%CI -12.24, -4.11), respectively. These differences were maintained regardless of the type of study, secondary outcomes also favored TXA, and there was no report of adverse effects. TXA reduces blood loss and the need for transfusion when compared to placebo/no intervention. The available studies on this topic suggest its use in these patients and its implementation in surgery protocols.