Abstract Body: Background
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, reduces mortality and haematoma expansion in spontaneous ICH.

Objective
We aim to assess the clinical effectiveness of TXA after ICH and determine whether TXA should be used in clinical practice.

Design
TICH-3 is a pragmatic phase III prospective double-blinded randomised placebo-controlled trial.

Population Studied (including sample size)
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 (GCS<5) and palliative care.

Intervention(s)
Rapid emergency consent will take place 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. Patients, relatives, researchers, and outcome assessors will be masked to treatment allocation.

Outcome Measure(s)
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.

Analysis
The evaluation of the primary outcome will be performed using regression models for binary outcomes, with adjustment for key prognostic factors. Absolute and relative measures of effect and 95% confidence intervals will be presented. The primary outcome will also be investigated in prespecified subgroups using appropriate interaction terms. The model will be fully specified in the SAP.

Trial Status
As of 17^th of October 2024, 1246 (22%) participants have been recruited by 104 sites from 10 countries for the TICH-3 trial.

Conclusions
TICH-3 results will provide definitive evidence for the effectiveness of TXA. This could change clinical practice globally for a disease with few treatment options.