Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial

Abstract

Background: Studies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in intracerebral haemorrhage patients susceptible to haemorrhage expansion.

Methods: We did a prospective, double-blind, randomised, placebo-controlled trial at 10 stroke centres in China. Acute supratentorial intracerebral haemorrhage patients were eligible if they had indication of haemorrhage expansion on admission imaging (eg, spot sign, black hole sign or blend sign), and were treatable within 8 hours of symptom onset. Patients were randomly assigned (1:1) to receive either tranexamic acid or a matching placebo. The primary outcome was intracerebral haematoma growth (>33% relative or >6 mL absolute) at 24 hours. Clinical outcomes were assessed at 90 days.

Results: Of the 171 included patients, 124 (72.5%) were male, and the mean age was 55.9±11.6 years. 89 patients received tranexamic acid and 82 received placebo. The primary outcome did not differ significantly between the groups: 36 (40.4%) patients in the tranexamic acid group and 34 (41.5%) patients in the placebo group had intracranial haemorrhage growth (OR 0.96, 95% CI 0.52 to 1.77, p=0.89). The proportion of death was lower in the tranexamic acid treatment group than placebo group (8.1% vs 10.0%), but there were no significant differences in secondary outcomes including absolute intracranial haemorrhage growth, death and dependency.

Conclusions: Among patients susceptible to haemorrhage expansion treated within 8 hours of stroke onset, tranexamic acid did not significantly prevent intracerebral haemorrhage growth. Larger studies are needed to assess safety and efficacy of tranexamic acid in intracerebral haemorrhage patients.

Keywords: CT; CT angiography; drug; hemorrhage; stroke.

Figure 1

Trial profile. GCS, glasgow coma scale; ICH, intracerebral haemorrhage; TXA, tranexamic acid.

Figure 2

Post hoc forest plot of primary outcome in subgroups stratified by demographic and clinical characteristics. OR less than 1 favours tranexamic acid over placebo. GCS, Glasgow Coma Scale; NIHSS, National Institutes of Health Stroke Scale; SBP: systolic blood pressure; TXA, tranexamic acid.

Figure 3

Modified Rankin Scale (mRS) distribution at 90 days. A score of 0 represents no symptoms, 1 represents no disability despite symptoms, 2 represents slight disability but able to look after own affairs, 3 represents moderate disability but able to walk without assistance, 4 represents moderately severe disability (unable to walk or attend to own bodily needs), 5 represents severely disabled (bedridden and requiring constant nursing care) and 6 represents death. GenOR=1.11 (0.65 to 1.90), p=0.70. TXA, tranexamic acid.

Figure 4

Post hoc forest plot of primary outcome in subgroups stratified by imaging characteristics. OR less than 1 favours tranexamic acid over placebo. ICH, intracerebral haemorrhage; TXA, tranexamic acid.