Tranexamic acid for hyperacute primary IntraCerebral
Haemorrhage (TICH-2): an international randomised,
placebo-controlled, phase 3 superiority trial
Nikola Sprigg, Katie Flaherty, et al.
The Lancet, Published Online
May 16, 2018.
Abstract:
Background:
Tranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We
aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke
due to intracerebral haemorrhage.
Methods:
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) 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. Randomisation was done centrally in real time via a secure website, with stratification by
country and minimisation on key prognostic factors. Treatment allocation was concealed from patients, outcome
assessors, and 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
and minimisation criteria. All analyses were done on an intention-to-treat basis. This trial is registered with the
ISRCTN registry, number ISRCTN93732214.
Findings:
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 [aOR] 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%]), and 90 (521 [45%]
vs 556 [48%]).
Interpretation:
Functional status 90 days after intracerebral haemorrhage did not differ significantly between patients
who received tranexamic acid and those who received placebo, despite a reduction in early deaths and serious adverse
events. Larger randomised trials are needed to confirm or refute a clinically significant treatment effect.
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