A Phase 2 interventional study of Tranexamic Acid and Normal saline in Intracerebral Haemorrhage, sponsored by Neuroscience Trials Australia. Completed at 25 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Neuroscience Trials Australia · Phase 2, Interventional, and Treatment
The study is a 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 in patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared to placebo.
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 326 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 144 patients is promising, using the methodology of Mehta and Pocock. The maximum sample size is capped at 326. 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.
457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.
This study's enrollment of 201 is above the median of 100 across 269 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Neuroscience Trials Australia is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous tranexamic acid 1000 mg in 100 mL 0.9% NaCl (or in 50ml syringe with 0.9% NaCl) over 10 minutes followed by 1000 mg in 500 mL 0.9% NaCl infusion over 8 hours.
Drug: Tranexamic Acid
100 mls (or in 50ml syringe) intravenous 0.9%NaCl over 10 minutes followed by 500 ml intravenous 0.9% NaCl infusion over 8 hours.
Drug: Normal saline
Investigational product given within 2 hours of symptom onset
Placebo given within 2 hours of symptom onset
Also known as: 0.9%NaCl
Haematoma growth by 24±6 hours as defined by either ≥33%or ≥6ml increase from baseline ICH volume (mls)
Relative ICH haematoma growth
Time frame: 24 hours(plus or minus 6 hours)
Haematoma growth by 24±6 hours as defined by ≥33%or ≥6ml increase from baseline in intracerebral haematoma volume, or any increase intraventricular haematoma volume
ICH or IVH growth at 24 hours ±6 hours from baseline
Time frame: 24 hours ±6 hours
Absolute haematoma growth by 24±6 hours
ICH growth as defined by either ≥33%or ≥6ml increase from baseline from baseline, adjusted for baseline ICH volume
Time frame: 24 hours ±6 hours
Relative haematoma growth by 24±6 hours
Relative ICH growth volume, adjusted for baseline ICH volume
Time frame: 24 hour ±6 hours
Absolute intraventricular haematoma growth by 24 hours ±6 hours
IVH growth at 24 hours ±6 hours from baseline
Time frame: 24 hours ±6 hours
Absolute intracerebral plus intraventricular haematoma growth by 24±6 hours
ICH plus IVH growth from baseline
Time frame: 24 hours ±6 hours
The number of patients with mRS 0-3 or back to pre-stroke level at 3 months
mRS 0-3 or back to pre-stroke level at 3 months
Time frame: 90 days ± 7 days
The number of patients with mRS 0-4 or back to pre-stroke level at 3 months
mRS 0-4 or back to pre-stroke level at 3 months
Time frame: 90 days ± 7 days
Categorical shift in mRS at 3 months
mRS 0-4 or back to pre-stroke level, or mRS 0-3 or back to pre-stroke level (with lowest mRS score being the better outcome)
Time frame: 90 days ± 7 days
Major thromboembolic events (myocardial infarction, ischaemic stroke, or pulmonary embolism) within 3 months
Safety outcome
Time frame: 3 months from baseline
Death within 3 months
Safety outcome
Time frame: 3 months from baseline
Death within 7 days
Safety outcome
Time frame: 7 days from baseline
Ran from Mar 2018 to primary completion in May 2023, 62 months.
Of 24 phase 2 interventional studies under Cerebral Hemorrhage, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 62. This study's 62 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid
Neuroscience Trials Australia