Sprigg N, et al. - An international, randomised placebo-controlled trial was performed to evaluate whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage. Despite a reduction in early deaths and serious adverse events, functional status 90 days after intracerebral haemorrhage did not differ significantly between patients who received tranexamic acid and those who received placebo.

Methods

• This trial was conducted on adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries.
• Members were randomly assigned (1:1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset.
• They performed randomisation centrally in real time via a secure website, with stratification by country and minimisation on key prognostic factors.
• After that, treatment allocation was concealed from patients, outcome assessors, and all other health-care workers involved in the trial.
• Using ordinal logistic regression with adjustment for stratification and minimisation criteria, the primary outcome was functional status at day 90, measured by shift in the modified Rankin Scale.
• All examinations were done on an intention-to-treat basis.

Results

• Between March 1, 2013, and Sept 30, 2017, two thousand, three hundred twenty-five participants were recruited.
• One thousand, one hundred sixty-one patients received tranexamic acid and one thousand, one hundred sixty-four received placebo; the treatment groups were well balanced at baseline.
• For 2307 (99%) participants, the primary outcome was assessed.
• They observed that the primary outcome, functional status at day 90, did not differ significantly between the groups (adjusted odds ratio [aOR] 0·88, 95% CI 0·76–1·03, p=0·11).
• Findings revealed that although there were fewer deaths by day 7 in the tranexamic acid group (101 [9%] deaths in the tranexamic acid group vs 123 [11%] deaths in the placebo group; aOR 0·73, 0·53–0·99, p=0·0406), there was no difference in case fatality at 90 days (250 [22%] vs 249 [21%]; adjusted hazard ratio 0·92, 95% CI 0·77–1·10, p=0·37).
• It was observed in the findings that fewer patients had serious adverse events after tranexamic acid than after placebo by days 2 (379 [33%] patients vs 417 [36%] patients), 7 (456 [39%] vs 497 [43%]), and 90 (521 [45%] vs 556 [48%]).