Hyperacute primary intracerebral haemorrhage (stroke) Circulatory System Intracerebral haemorrhage
Conditions
Interventions
Current interventions as of 23/02/2026:
Pragmatic phase III prospective blinded randomised placebo-controlled trial performed in two phases: a 30-month internal pilot phase with pre-specified progre
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 23/02/2026: TICH-3: Adult patients with ICH confirmed on brain imaging within 4.5 hours of symptom onset DASH-2: Adult patients taking antiplatelets with ICH confirmed on brain imaging within 24 hours of symptom onset _____ Previous key inclusion criteria: Adult patients with ICH confirmed on brain imaging within 4.5 hours of symptom onset
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 23/02/2026: TICH-3 comparison: 1. Patient with a known indication for TXA treatment (e.g. traumatic brain injury) 2. Patient with contraindication for TXA treatment 3. Patient known to be taking therapeutic anticoagulation with warfarin or low molecular weight heparin at the time of enrolment. Patients taking direct oral anticoagulants can be included and are not excluded. 4. Massive ICH for which haemostatic treatment seems futile (This would ordinarily be when haematoma volume is estimated as larger than 60ml) 5. Severe coma (Glasgow Coma Scale 60 ml 5. Palliative care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome(s) as of 23/02/2026: TICH-3: Death at 7 days, measured by the number of participants who have died by Day 7 DASH-2: Death or dependency at Day 180 _____ Previous primary outcome(s): Death at 7 days, measured by the number of participants who have died by Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 23/02/2026: TICH-3: 1. Disability measured by modified Rankin Scale (mRS) at Day 180 2. Venous thromboembolism/ischaemic events/seizures measured by review of medical notes at Day 7 3. Quality of life measured by EQ-5D visual analogue score (VAS) at Day 180 4. Cognition measured by AD-8 at Day 180 5. Health economics (use of antihypertensive medication, Do Not Resuscitate orders, admission to intensive care, neurosurgical intervention, hospital length of stay and discharge disposition) measured by review of medical notes at Day 180 DASH-2: 1. Safety: Symptomatic hyponatraemia or fluid overload at 24 hours (as defined in the protocol); early mortality < 7days, <28 days, and up to day 180; serious adverse events (including thrombotic events) up to day 180. 2. Functional/other: Quality of Life (EuroQol, EQ-5D-5L, VAS), and cognition (AD-8) at day 180. 3. Health economics: Health economic assessment (EQ-5D), length of hospital stay, discharge destination. _____ Previous key secondary outcome(s): 1. Disability measured by modified Rankin Scale (mRS) at Day 180 2. Venous thromboembolism/ischaemic events/seizures measured by review of medical notes at Day 7 3. Quality of life measured by EQ-5D visual analogue score (VAS) at Day 180 4. Cognition measured by AD-8 at Day 180 5. Health economics (use of antihypertensive medication, Do Not Resuscitate orders, admission to intensive care, neurosurgical intervention, hospital length of stay and discharge disposition) measured by review of medical notes at Day 180 | — |
Countries
Denmark, England, France, Georgia, Ireland, Italy, Malaysia, Scotland, Spain, Sweden, Switzerland, United Kingdom, Wales
Outcome results
None listed