Stroke Circulatory System Intracerebral haemorrhage
Conditions
Interventions
Intravenous tranexamic acid: 1g loading dose given as 100 ml infusion over 10 minutes, followed by another 1g in 250 ml infused over 8 hours. Comparator ? matching placebo (normal saline 0.9%) adminis
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult (=18 years, either sex) patients with acute primary intracerebral haemorrhage (PICH) within 8 hours of stroke onset (where stroke onset time is unknown, the time of when last known well will be used)
Exclusion criteria
Exclusion criteria: 1. Patients with intracerebral haemorrhage secondary to anticoagulation, thrombolysis or known underlying structural abnormality such as arterial venous malformation, aneurysm, tumour, venous thrombosis as cause for the intracerebral haemorrhage. Note it is not necessary to exclude an underlying abnormality prior to enrolment, but where a secondary cause of haemorrhage is known, these patients should not be recruited. 2. Patients for whom tranexamic acid is thought to be contraindicated 3. Patients with premorbid dependency (mRS>4) 4. Participation in another drug trial concurrently 5. Prestroke life expectancy <3 months (e.g. advanced metastatic cancer) 6. Coma ? Glasgow coma scale <5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether tranexamic acid is safe and reduces death or dependency after primary intracerebral haemorrhage (PICH) Death or dependency (ordinal shift on mRS) at day 90 will be analysed by intention-to-treat using ordinal logistic regression (OLR), with adjustment for minimisation factors. The assumption of proportional odds will be tested using the likelihood ratio test. Comparison of tranexamic acid versus control. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. At day 7 (or discharge if sooner), neurological impairment (NIHSS) 2. At day 90, disability (Barthel index), Quality of Life (EuroQoL), cognition, cognition and mood (TICS and ZDS) 3. Safety: death, serious adverse events, thromboembolic events, seizures 4. Costs: length of stay in hospital, re-admission, institutionalisation 5. Radiological efficacy/safety (CT scan): change in haematoma volume from baseline to 24 hours, haematoma location, and new infarction | — |
Countries
Denmark, England, Georgia, Hungary, Ireland, Italy, Malaysia, Poland, Spain, Sweden, Switzerland, Turkey, United Kingdom
Outcome results
None listed