Could Tranexamic Acid Improve Outcomes After Intracerebral Hemorrhage?

The authors of a new study have found that treatment with tranexamic acid—commonly used to prevent death due to bleeding after trauma or postpartum hemorrhage—may reduce early death and serious adverse events compared with placebo among individuals with intracerebral hemorrhage.

However, they noted, tranexamic acid was not found to improve 90-day functional status vs placebo in this patient population.
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For their study, the researchers recruited and assessed 2325 participants with intracerebral hemorrhage from acute stroke units at 124 hospitals across 12 countries.

Participants were randomly assigned to treatment with 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid (n = 1161) or a matching placebo (n = 1164), within 8 hours of symptom onset.

The primary outcome—defined as functional status at day 90—was measured by shift in the modified Rankin Scale. Ordinal logistic regression was used, and results were adjusted for stratification and minimization criteria.

Ultimately, 2307 (99%) participants were assessed for the primary outcome. Findings from the study showed that there was no significant difference in the primary outcome between groups (adjusted odds ratio [aOR] 0.88).

Furthermore, although fewer deaths occurred by day 7 in the tranexamic group than in the placebo group, (101 vs 123 deaths; aOR 0.73), no between-group difference was observed for 90-day case fatality (250 vs 249; adjusted hazard ratio 0.92).

Fewer tranexamic acid-treated participants experienced serious adverse events than placebo-treated participants at day 2 (379 vs 417 patients), day 7 (456 vs 497 patients), and day 90 (521 vs 556 patients).

 “Larger randomized trials are needed to confirm or refute a clinically significant treatment effect,” the researchers concluded.

—Christina Vogt

Reference:

Sprigg N, Flaherty K, Appleton JP, et al; TICH-2 Investigators. Tranexamic acid for hyperacute primary IntraCerebral Hemorrhage (TICH-2): an international randomized, placebo-controlled, phase 3 superiority trial [Published online May 16, 2018]. Lancet. https://doi.org/10.1016/S0140-6736(18)31033-X