Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial


Tranexamic acid can prevent death due lớn bleeding after trauma và post-partum haemorrhage. We aimed khổng lồ assess whether tranexamic acid reduces haematoma expansion & improves outcome in adults with stroke due to lớn intracerebral haemorrhage.

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We did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1:1) lớn 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. Randomisation was done centrally in real time via a secure website, with stratification by country và minimisation on key prognostic factors. Treatment allocation was concealed from patients, outcome assessors, và all other health-care workers involved in the trial. The primary outcome was functional status at day 90, measured by shift in the modified Rankin Scale, using ordinal logistic regression with adjustment for stratification và minimisation criteria. All analyses were done on an intention-to-treat basis. This trial is registered with the ISRCTN registry, number ISRCTN93732214.
We recruited 2325 participants between March 1, 2013, and Sept 30, 2017. 1161 patients received tranexamic acid and 1164 received placebo; the treatment groups were well balanced at baseline. The primary outcome was assessed for 2307 (99%) participants. The primary outcome, functional status at day 90, did not differ significantly between the groups (adjusted odds ratio 0·88, 95% CI 0·76–1·03, p=0·11). 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). 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%>), & 90 (521 <45%> vs 556 <48%>).
Functional status 90 days after intracerebral haemorrhage did not differ significantly between patients who received tranexamic acid và those who received placebo, despite a reduction in early deaths and serious adverse events. Larger randomised trials are needed khổng lồ confirm or refute a clinically significant treatment effect.
National Institute of Health Research Health công nghệ Assessment Programme và Swiss Heart Foundation.
Spontaneous (non-traumatic) intracerebral haemorrhage is the cause of up khổng lồ 20% of all strokes, yet accounts for nearly half of all stroke deaths worldwide. Survival after intracerebral haemorrhage has not changed for several decades,
Incidence, case fatality, và functional outcome of intracerebral haemorrhage over time, according to lớn age, sex, and ethnic origin: a systematic reviews and meta-analysis.
và the only intervention that improves functional outcome is early intensive blood pressure lowering.

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Around a quarter of intracerebral haemorrhages are complicated by haematoma expansion, which most often occurs within the first few hours, but can occur at up khổng lồ 24 h, và is associated with poor outcomes.