Efficacy and safety of tranexamic acid in acute traumatic brain injury: a systematic review and meta-analysis of randomi
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SYSTEMATIC REVIEW
Efficacy and safety of tranexamic acid in acute traumatic brain injury: a systematic review and meta‑analysis of randomized‑controlled trials Kumait Al Lawati1,2,3, Sameer Sharif1,2* , Said Al Maqbali1,3, Hussein Al Rimawi1, Andrew Petrosoniak4, Emilie P. Belley‑Cote2,5, Sunjay V. Sharma2,6, Justin Morgenstern7, Shannon M. Fernando8,9, Julian J. Owen1,2, Michelle Zeller10, David Quinlan1, Waleed Alhazzani2,11 and Bram Rochwerg2,11 © 2020 Springer-Verlag GmbH Germany, part of Springer Nature
Abstract 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In this systematic review and meta-analysis, we searched MEDLINE, PubMed, EMBASE, CINHAL, ACPJC, Google Scholar, and unpublished sources from inception until June 24, 2020 for randomized-controlled trials com‑ paring TXA and placebo in adults and adolescents (≥ 15 years of age) with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. Keywords: Randomized, Clinical trial, Tranexamic acid, Traumatic, Brain injury Introduction *Correspondence: [email protected] 2 Division of Critical Care, Department of Medicine, McMaster University, Hamilton, ON, Canada Full author information is available at the end of the article Kumait Al Lawati and Sameer Sharif the first two authors equally contributed to the work.
Traumatic brain injury (TBI) is a leading cause of mortality and morbidity worldwide [1–3], with the vast majority of patients presenting with intracranial bleeding [4]. In particular, TBI is more common in low- and middleincome countries with youth and adolescents being
disproportionately affected [5, 6]. Progressive hematoma expansion secondary to high levels of fibrinolysis and coagulopathy has been associated with worse prognosis and increased risk of intracranial
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