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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Gosford Hospital
Kanwal, New South Wales, Australia
John Hunter Hospital
Newcastle, New South Wales, Australia
St. Vincent's Hospital
Sydney, New South Wales, Australia
ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume.
Time frame: 24+/-3 hours
Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism)
Time frame: Within 90+/-7 days
Absolute ICH growth volume by 24±3 hours, adjusted for baseline ICH volume
Time frame: 24+/-3 hours
Absolute intraventricular haematoma (IVH) growth volume by 24±3 hours, adjusted for baseline IVH volume
Time frame: 24+/-3 hours
modified Rankin Scale (mRS) score of 0-4 at 3 months
Time frame: 90+/-7 days
modified Rankin Scale (mRS) score of 0-3 at 3 months
Time frame: 90+/-7 days
Categorical shift in mRS at 3 months, subject to the validity of proportional odds assumption
Time frame: 90+/-7 days
Death due to any cause by 3 months
Time frame: within 90+/-7 days
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Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
...and 1 more locations