Objective: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
Keywords: Craniosynostosis; Meta-analysis; Systematic review; Tranexamic acid.
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