RESUMEN
PURPOSE: With the publication of a large randomized-controlled trial (RCT) suggesting that tranexamic acid (TXA) may improve head-injury-related deaths, we aimed to determine the safety and efficacy of TXA in acute traumatic brain injury (TBI). METHODS: In this systematic review and meta-analysis, we searched MEDLINE, PubMed, EMBASE, CINHAL, ACPJC, Google Scholar, and unpublished sources from inception until June 24, 2020 for randomized-controlled trials comparing TXA and placebo in adults and adolescents (≥ 15 years of age) with acute TBI. We screened studies and extracted summary estimates independently and in duplicate. We assessed the quality of evidence using the grading of recommendations assessment, development, and evaluation approach. This study is registered with PROSPERO (CRD42020164232). RESULTS: Nine RCTs enrolled 14,747 patients. Compared to placebo, TXA had no effect on mortality (RR 0.95; 95% CI 0.88-1.02; RD 1.0% reduction; 95% CI 2.5% reduction to 0.4% increase, moderate certainty) or disability assessed by the Disability Rating Scale (MD, - 0.18 points; 95% CI - 0.43 to 0.08; moderate certainty). TXA may reduce hematoma expansion on subsequent imaging (RR 0.77; 95% CI 0.58-1.03, RD 3.6%, 95% CI 6.6% reduction to 0.5% increase, low certainty). Risks of adverse events (all moderate, low, or very low certainty) were similar between placebo and TXA. CONCLUSIONS: In patients with acute TBI, TXA probably has no effect on mortality or disability. TXA may decrease hematoma expansion on subsequent imaging; however, this outcome is likely of less importance to patients. The use of TXA probably does not increase the risk of adverse events.