The aim of the study is to test if intracerebral haemorrhage (ICH) patients who have contrast extravasation on computed tomography angiography, the "spot sign", have lower rates of haematoma growth when treated with tranexamic acid within 4.5 hours of stroke onset, compared to placebo.
- Tranexamic Acid (Cyklokapron)Drug
ARM 1: Kind: Experimental Label: Tranexamic Acid Description: Intravenous tranexamic acid 1000 mg in 100 mL 0.9% NaCl over 10 minutes followed by 1000 mg in 500 mL 0.9% NaCl infusion over 8 hours.
- Placebo Drug
ARM 1: Kind: Experimental Label: Placebo Description: Intravenous placebo in 100 mL 0.9% NaCl over 10 minutes followed by 500 mL 0.9% NaCl infusion over 8 hours.
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume.||24+/-3 hours||No|
|Secondary||Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism)||Within 90+/-7 days||Yes|
|Secondary||Absolute ICH growth volume by 24±3 hours, adjusted for baseline ICH volume||24+/-3 hours||No|
|Secondary||Absolute intraventricular haematoma (IVH) growth volume by 24±3 hours, adjusted for baseline IVH volume||24+/-3 hours||No|
|Secondary||modified Rankin Scale (mRS) score of 0-4 at 3 months||90+/-7 days||No|
|Secondary||modified Rankin Scale (mRS) score of 0-3 at 3 months||90+/-7 days||No|
|Secondary||Categorical shift in mRS at 3 months, subject to the validity of proportional odds assumption||90+/-7 days||No|
|Secondary||Death due to any cause by 3 months||within 90+/-7 days||No|