Tranexamic acid for traumatic brain injury: a systematic review and meta-analysis

Shahriar Zehtabchi, Samah G Abdel Baki, Louise Falzon, Daniel K Nishijima, Shahriar Zehtabchi, Samah G Abdel Baki, Louise Falzon, Daniel K Nishijima

Abstract

Objective: The antifibrinolytic agent tranexamic acid (TXA) has demonstrated clinical benefit in trauma patients with severe bleeding, but its effectiveness in patients with traumatic brain injury (TBI) is unclear. We conducted a systematic review to evaluate the following research question: In ED patients with or at risk of intracranial hemorrhage (ICH) secondary to TBI, does TXA compared to placebo improve patients' outcomes?

Methods: MEDLINE, EMBASE, CINAHL, and other databases were searched for randomized controlled trial (RCT) or quasi-RCT studies that compared the effect of TXA to placebo on outcomes of TBI patients. The main outcomes of interest included mortality, neurologic function, hematoma expansion, and adverse effects. We used "Grading quality of evidence and strength of recommendations" to assess the quality of trials. Two authors independently abstracted data using a data collection form. Results from studies were pooled when appropriate.

Results: Of 1030 references identified through the search, 2 high-quality RCTs met inclusion criteria. The effect of TXA on mortality had a pooled relative risk of 0.64 (95% confidence interval [CI], 0.41-1.02); on unfavorable functional status, a relative risk of 0.77 (95% CI, 0.59-1.02); and on ICH progression, a relative risk of 0.76 (95% CI, 0.58-0.98). No serious adverse effects (such as thromboembolic events) associated with TXA group were reported in the included trials.

Conclusion: Pooled results from the 2 RCTs demonstrated statistically significant reduction in ICH progression with TXA and a nonstatistically significant improvement of clinical outcomes in ED patients with TBI. Further evidence is required to support its routine use in patients with TBI.

Conflict of interest statement

Conflict of interest: SZ, LF, and DKN have no conflict of interest to report. SGA owns stock options in Bio-Signal Group Corporation and is a co-inventor on US patents pending 61/554,743 and 13/284, and 886. He is also the principal investigator of an NIH funded trial 5R41HD072881-02.

Copyright © 2014 Elsevier Inc. All rights reserved.

Figures

Figure 1
Figure 1
Flow diagram of study selection process for systematic review.
Figure 2
Figure 2
Forest plots representing the effect of tranexamic acid on outcome of patients with traumatic brain injury. a- defined as death, vegetative state, or fully dependent requiring attention day and night or dependent but not requiring constant attention b- defined as ≥ 25% increase in total volume from all hemorrhagic lesions between initial and repeat CT (at 24–48 hours) Abbreviations: RR, relative risk; CI, confidence intervals; df, degrees of freedom

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