Outcome 1 year after ICH: Data from the Tranexamic acid for IntraCerebral Haemorrhage 2 (TICH-2) trial

Zhe Kang Law, Chaamanti Sivakumar Menon*, Lisa J Woodhouse, Jason Philip Appleton, Rustam Al-Shahi Salman, Thompson Robinson, David Werring, Christine Roffe, Robert A Dineen, Philip Michael Bath, Nikola Sprigg

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

INTRODUCTION: The Tranexamic acid for IntraCerebral Haemorrhage-2 (TICH-2) trial reported no significant improvement in death and dependency at day 90 despite reductions in haematoma expansion, early neurological deterioration and early death. However, significant recovery after stroke, particularly intracerebral haemorrhage (ICH), may take more than 3 months. Here we report the participant outcomes at 1 year after stroke.

PATIENTS AND METHODS: TICH-2 was a prospective randomised controlled trial that tested the efficacy and safety of tranexamic acid in spontaneous ICH when given within 8 h of onset. Patients with ICH on anticoagulation were excluded. Centralised blinded telephone follow up was performed for patients from the United Kingdom at 1 year. The primary outcome was modified Rankin Scale at 1 year. Secondary outcomes included Barthel index, Telephone Interview Cognitive Status-modified, EuroQoL-5D and Zung Depression Scale. This was a prespecified secondary analysis of the TICH-2 trial.

RESULTS: About 2325 patients were recruited into the trial (age 68.9 ± 13.8 years; 1301 male, 56%). About 1910 participants (82.2%) were eligible for day 365 follow up. 57 patients (3.0%) were lost to follow up. Tranexamic acid did not reduce the risk of poor functional outcome at 1 year (adjusted OR 0.91 95% CI 0.77-1.09; p  = 0.302). However, Cox proportional hazard analysis revealed significant survival benefit in the tranexamic acid group (adjusted HR 0.83, 95% CI 0.70-0.99; p  = 0.038).

CONCLUSION: There was no difference in functional outcome at 1 year after ICH. Tranexamic acid may reduce mortality at 1 year without an increase in severely dependent survivors. But this should be interpreted with caution as this is a result of secondary analysis in a neutral trial.

Original languageEnglish
Pages (from-to)23969873241265939
JournalEuropean Stroke Journal
Early online date30 Jul 2024
DOIs
Publication statusE-pub ahead of print - 30 Jul 2024

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