Abstract Number: Esoc2026ot131 Tranexamic Acid for Intracerebral Haemorrhage 3 (Tich-3): Rationale and Design of a Phase Iii Double Blind Randomised Controlled Multi-Centred Superiority Trial

Abstract Background and aims Intracerebral haemorrhage (ICH) a medical emergency causes more than 1.7 million strokes worldwide/year with over 40% mortality. Tranexamic acid (TXA) when given early, may reduce mortality and haematoma expansion in spontaneous ICH. Methods We aim to assess the clinical effectiveness of TXA after ICH and determine whether TXA should be used in clinical practice. Results TICH-3 is a pragmatic phase III prospective double-blinded randomised placebo-controlled trial. 5500 adult patients (≥18) with spontaneous ICH (including direct oral anticoagulants (DOAC) associated ICH) will be recruited within 4.5 hours of onset across UK and International sites. Exclusion criteria include known indication for TXA, contraindications for TXA, known to be on anticoagulation (except DOAC), massive ICH(60ml), severe coma (GCS5) and palliative care. Rapid emergency consent utilised, and patients will be randomised (1:1) by simple randomisation to receive intravenous TXA 2g; 1g bolus loading dose given as 100ml infused over 10 minutes, followed by another 1g in 250ml infused over 8hrs or matching comparator. The primary outcome is mortality by day 7. Secondary outcomes include dependency (using the modified Rankin Score), Quality of Life at day 180, serious adverse events (SAE) up to 7 days, and fatal SAEs up to day 180. Conclusions The results of TICH-3 will determine whether tranexamic acid should be implemented into standard of care for spontaneous intracerebral haemorrhage. Conflict of interest