Last updated on December 2019

STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units

Brief description of study

The study will be prospective phase II randomised, double-blind, placebo-controlled, investigator-driven trial in acute intracerebral haemorrhage patients.

The study has 2 arms with 1:1 randomisation to either intravenous Tranexamic acid or placebo and will test the hypothesis that ICH (intracranial haemorrhage) patients treated with intravenous tranexamic acid within 2 hours of symptom onset will have lower rates of haematoma growth than compared to placebo.

Detailed Study Description

The trial will include patients with acute spontaneous ICH, who are 18 years of age and are eligible for treatment within 2 hours of stroke onset. A sample size of 62 patients is calculated to give 80% power to detect a large effect size assuming mean relative ICH haematoma growth of 38% in the placebo arm compared to 19% in the active treatment arm and standard deviation of 19%, inflated for nonparametric analysis. Adaptive increase in sample size will be performed if the result of interim analysis of the first 50 patients is promising, using the methodology of Mehta and Pocock.1 The maximum sample size is capped at 124. Standard CT for initial diagnosis of suspected stroke patients will be performed. Neurological impairment and functional scores will be measured by a neurologist or health care professional trained in their administration. The assessors will be blinded to the treatment group. Patients eligible for the RCT will be randomised in a 1:1 ratio to receive either Tranexamic acid or placebo stratified by treating centre and utilising randomly permuted blocks of random size.

Clinical Study Identifier: NCT03385928

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Alfred Hospital

Melbourne, Australia
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Royal Melbourne Hospital

Melbourne, Australia
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Box Hill Hospital

Box Hill, Australia
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Monash Medical Centre

Clayton, Australia
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