Intracerebral hemorrhage affects approximately 3.4 million individuals worldwide annually. Hematoma growth during intracerebral hemorrhage is associated with significant morbidity and mortality, and previous trials have suggested that treatment with tranexamic acid may be beneficial. In an international, phase 2 randomized, double-blinded trial at 25 sites (Stopping Intracerebral Haemorrhage with Tranexamic Acid for Hyperacute Onset Presentation including Mobile Stroke Units [STOP-MSU]), researchers hypothesized that treatment with tranexamic acid within two hours of intracerebral hemorrhage onset would attenuate hematoma growth. During the study, 201 patients (median age, 66 years; 41% female) were randomized to receive either intravenous tranexamic acid (n=103) or saline placebo (n=98). The percentage of patients with hematoma growth was similar in both study arms: 43% in the tranexamic acid arm compared to 38% in the placebo arm (adjusted odds ratio, 1.31; 95% CI, 0.72 to 2.40); and the median hematoma growth was 1.2 mL in both arms. Furthermore, no differences in mortality or thromboembolic events were observed at 7 or 90 days. In this phase 2 trial, tranexamic acid did not reduce hematoma growth in patients with intracerebral hemorrhage when treated within two hours of symptom onset. Results from an ongoing phase 3 trial with 5,500 participants with intracerebral hemorrhage treated with tranexamic acid or placebo within 5 hours of symptom onset will help illuminate the effectiveness of tranexamic acid treatment for these patients.
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