Treatment With Tranexamic Acid Shows Limited Effectiveness in Stopping Brain Bleeds

February 25, 2020
By Alex Morrisson LOS ANGELES -- February 24, 2020 -- Patients with stroke who are identified as having intracerebral haemorrhage (ICH) may be helped by treatment with tranexamic acid, according to a study presented here at the 2020 International Stroke Conference (ISC). While there were differences in outcomes that favoured treatment with tranexamic acid, the low number of patients in the study prevented the trial from having statistically significant results, said Nawaf Yassi, PhD, Royal Melbourne Hospital, Melbourne, Australia. In the phase 2 Spot Sign and Tranexamic Acid on Preventing ICH Growth - Australasia Trial (STOP-AUST), Dr. Yassi and colleagues randomised 100 patients who demonstrated the CT angiography spot sign 1:1 to receive 2 g tranexamic acid (1 g over 10 minutes followed by 1 g over 8 hours) or matching placebo within 4.5 hours of stroke onset. The researchers found that ICH growth >33% or >6 mL above baseline volume occurred in 44% of patients taking tranexamic acid versus 52% of those taking placebo (adjusted odds ratio [aOR] = 0.72; 95% confidence interval [CI], 0.32-1.59; P = .41). Median absolute haematoma growth was 1.9 mL in patients who took tranexamic acid versus 3.4 mL those who took placebo (adjusted median difference = -1.8 mL; 95% CI, -5.2 to 1.5; P = .28). The study showed a trend towards reduced presence of haematoma growth in the prespecified subgroup treated ≤3 hours from stroke onset (aOR = 0.41; 95% CI, 0.15-1.12; n = 66), but not in treated those 3 to 4.5 hours from stroke onset (aOR = 2.45; 95% CI, 0.52-11.57; P = .06.) This was supported by a post hoc analysis of those treated ≤2 hours from stroke onset (aOR = 0.19; 95% CI, 0.03-1.15; P = .07; n = 27). After 90 days, about 56% of the patients who received tranexamic acid and about 46% of those who received placebo had either returned to their baseline modified Rankin Scale status or had a score between 0 and 2, indicating minimal deficits from their stroke. Major adverse events such as thromboembolism or death were not statistically significantly different between the groups. There was 1 thromboembolic event in a patient who received tranexamic acid compared with 2 events in the placebo group. Among patients who took tranexamic acid, there were 13 deaths compared with 8 deaths among patients who took placebo. “Further trials using tranexamic acid are ongoing and [are] focusing on ultra-early treatment -- within 2 hours,” said Dr. Yassi. “This is where the greatest opportunity for intervention appears to be.” “Tranexamic acid is inexpensive, safe, and widely available,” he concluded. “Our results and others provide great impetus for further, focused research using this treatment.” ISC is sponsored by the American Heart Association and the American Stroke Association. [Presentation title: The Spot Sign and Tranexamic Acid on Preventing ICH Growth - Australasia Trial (STOP-AUST): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Abstract LB20]