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Meta-Analysis
. 2025 Jul;39(7):637-650.
doi: 10.1007/s40263-025-01185-5. Epub 2025 May 2.

Relationship between Tranexamic Acid Use and Safety in Patients with Acute Brain Injury: A Systematic Review and Meta-analysis of Mortality and Thromboembolic Events

Seungjoo Lee  1 , Moinay Kim  1 , Sae Min Kwon  2 , Min-Yong Kwon  2 , Chang-Hyun Kim  2 , Nak-Hoon Son  3 , Jae Hyun Kim  4
Affiliations
Meta-Analysis

Relationship between Tranexamic Acid Use and Safety in Patients with Acute Brain Injury: A Systematic Review and Meta-analysis of Mortality and Thromboembolic Events

Seungjoo Lee et al. CNS Drugs. 2025 Jul.

Abstract

Background: Tranexamic acid (TXA) is widely used to manage acute brain injuries, including subarachnoid hemorrhage, intracerebral hemorrhage, and traumatic brain injury. Despite its common usage, there is limited evidence on its safety in these conditions. We aimed to evaluate the impact of TXA on mortality and thromboembolic events in patients with acute brain injury.

Methods: A systematic search of MEDLINE/PubMed, Embase, and the Cochrane Central Register of Controlled Trials was conducted from inception to May 2024. We included randomized controlled trials (RCTs) comparing TXA with placebo in patients aged 15 years or older with confirmed acute brain injury. Two reviewers independently assessed study quality using the revised Cochrane Risk of Bias tool and extracted data on patient demographics, intervention details, and outcomes, including mortality, thromboembolic events, and seizures. Meta-analyses were performed using random effects models.

Results: Twenty-five RCTs with 16,677 participants (8584 TXA, 8093 control) were included. The relative risk (RR) for overall mortality was 0.96 (95% confidence interval (CI) 0.91-1.03, p = 0.2433), indicating a nonsignificant difference between the groups, with no substantial heterogeneity (I2 = 0% [0-45%]). Additionally, no significant differences were observed in 30-, 90-, or 180-day mortality. The RR for total thromboembolic events was 1.11 (95% CI 0.97-1.28, p = 0.1236), indicating a nonsignificant difference between the groups, with low heterogeneity (I2 = 15% [0-51%]). Similarly, no significant differences were observed in the incidences of deep vein thrombosis or pulmonary embolism, ischemic stroke or transient ischemic attack, acute coronary syndrome or myocardial infarction, or seizures. However, the administration of TXA for more than 1 day was associated with a significant increase in thromboembolic events (RR 1.22, 95% CI 1.03-1.44). Administering TXA beyond 8 h of injury was also associated with a significant increase in thromboembolic events (RR 1.16, 95% CI 1.02-1.33).

Conclusions: TXA administration does not significantly affect overall mortality or increase the risk of thromboembolic events in patients with acute brain injuries. However, prolonged use or delayed administration may be associated with an increased risk of thromboembolic events. These findings highlight the need for careful consideration of the duration and timing of TXA administration in clinical practice.

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Conflict of interest statement

Declarations. Funding: No funding was received for this study. Conflict of interest: The authors declare that they have no competing interests. Availability of data and material: The meta-analytic dataset was derived from previously published studies, and all included data can be verified through the original publications. The data that support the findings of this study are also available from the corresponding author upon reasonable request. Ethics approval: Not applicable. Consent to participate: Not applicable. Consent for publication: Not applicable. Code availability: The code used for this study is available from the corresponding author upon reasonable request. Author contributions: Contributed to the conception and design of the study: J.H.K., M.K., and S.J.L.; performed the title and abstract screening: J.H.K., M.Y.K., and S.M.K.; performed the data extraction: J.H.K., S.M.K., and S.J.L.; organized the data and created the characteristic tables: M.K. and S.J.L.; performed the data analysis: J.H.K. and N.H.S; wrote the first draft of the manuscript: J.H.K. and C.H.K. All authors contributed to manuscript revision, and read and approved the submitted version.

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