Tranexamic acid for spontaneous intracerebral hemorrhage: hematoma control without clinical benefits? A meta-analysis of RCTs

Abstract

Spontaneous intracerebral hemorrhage (sICH) is a serious form of stroke associated with high mortality and poor functional outcomes. Hematoma expansion critically affects prognosis, necessitating early intervention. Tranexamic acid (TXA), an antifibrinolytic, has an uncertain role in sICH. This meta-analysis synthesizes evidence from randomized controlled trials (RCTs) to evaluate the efficacy and safety of TXA in sICH. Comprehensive searches of PubMed, Scopus, Web of Science, and Cochrane Library identified RCTs comparing intravenous TXA to placebo in sICH, focusing on hematoma expansion. Data on functional outcomes, mortality, thromboembolic events, and quality of life were extracted. Cochrane RoB2 assessed the quality of studies. RevMan 5.4 was used for data analysis, employing fixed-effects models. Subgroup analyses were conducted based on time windows and patient subgroups. Eight RCTs (2974 patients) were included. TXA significantly reduced 24-h hematoma volume (MD = - 1.17 mL, 95% CI = - 1.97 to - 0.36), particularly when administered within 8 h (MD = - 1.71 mL, 95% CI = - 2.68 to - 0.74). However, odds of expansion, functional outcomes, 90-day mortality, thromboembolic events, and quality of life were similar between groups. Another subgroup analysis based on study populations revealed a significant effect of TXA on hematoma volume in studies involving sICH without a specific subgroup classification. However, no significant effect was observed in other subgroups, including sICH with spot sign, hypertensive ICH, and NOAC-associated ICH. TXA has been shown to reduce hematoma expansion in sICH, particularly when administered within 8 h of symptom onset, without a corresponding increase in thromboembolic events. However, this benefit has not translated into significant improvements in functional outcomes, mortality, or quality of life. As such, current evidence does not support the routine use of TXA in sICH, and further high-quality research is warranted.