A Phase 2 interventional study of Tranexamic Acid and Placebo in Intracerebral Haemorrhage and Stroke, sponsored by Neuroscience Trials Australia. Completed at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Neuroscience Trials Australia · Phase 2, Interventional, and Treatment
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.
457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.
This study's enrollment of 100 is close to 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.
Contrast extravasation within the haemorrhage, "spot sign", evaluated from the CTA according to three criteria, all of which must be present:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 over 10 minutes followed by 1000 mg in 500 mL 0.9% NaCl infusion over 8 hours.
Drug: Tranexamic Acid
Intravenous placebo in 100 mL 0.9% NaCl over 10 minutes followed by 500 mL 0.9% NaCl infusion over 8 hours.
Drug: Placebo
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
ICH growth
Exploratory analyses will be run with adjustments for baseline variables such as age, Glasgow Coma Scale (GCS), presence of IVH, and ICH location, and in the following subgroups: onset-to-treatment time (\<3 vs. \>3 hours); baseline ICH volume (\<30 vs. \>30 ml); anatomical location (deep, lobar, or cerebellar); IVH (absent vs. present); GCS (\>12 vs. 8-12) and age (\<70 vs. \>70). These analyses will be hypothesis generating, as the trial is not powered for them.
Time frame: 24+/-3 hours
modified Rankin Scale (mRS)
Exploratory analyses will be run with adjustments for baseline variables such as age, Glasgow Coma Scale (GCS), presence of IVH, and ICH location, and in the following subgroups: onset-to-treatment time (\<3 vs. \>3 hours); baseline ICH volume (\<30 vs. \>30 ml); anatomical location (deep, lobar, or cerebellar); IVH (absent vs. present); GCS (\>12 vs. 8-12) and age (\<70 vs. \>70). These analyses will be hypothesis generating, as the trial is not powered for them.
Time frame: 90+/-7 days
This study is completed, as verified in Feb 2020. 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