Printed from Voxsanity (voxsanity.com.au) — NCT04434807 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Stroke Trial, Recruiting
NCT04434807
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have had a recent brain bleed (called an intracerebral hemorrhage) in the upper part of the brain, where the bleed is at least 20mL in size
- People aged 18 or older
- People where surgery could begin within 8 hours of when symptoms first appeared, or within 8 hours of waking up with symptoms; people who initially had a smaller bleed that then grew larger and caused their condition to worsen may also be considered, as long as surgery can begin within 8 hours of that worsening
- People who have a moderate level of neurological impairment, based on a standard medical scoring tool (confirm with trial site)
- People who were largely independent before their stroke — either fully independent or needing only minor help at home, and able to manage on their own for at least a week
- People who have had a specific type of blood vessel scan (CTA or MRA) that showed no underlying blood vessel problems causing the bleed
Who may not be able to join:
- People whose brain bleed is located in the brainstem (the lower part of the brain)
- People whose brain bleed was caused by a head injury where the overall effects of the trauma, rather than the bleed itself, are considered the main cause of harm
- People with inherited or acquired bleeding or clotting disorders, or certain liver conditions that affect blood clotting (confirm with trial site)
- People with a very low platelet count (below 75,000), which affects the blood's ability to clot
- People who are on blood-thinning medications that cannot be reversed before the procedure; some blood thinners can be reversed with specific medications and may still be eligible, but people who have taken certain blood thinners in the last 48 hours without reversal are not eligible (confirm with trial site)
- People who have received a particular type of blood-thinning injection (GPIIb/IIIa antagonist) within the last 12 hours
- People who received clot-dissolving treatment (thrombolysis) less than 1 hour ago; people who had a brain bleed between 1 and 12 hours after receiving such treatment may be considered, but specific medications must be given beforehand (confirm with trial site)
- People who have taken part in another research study within the last 30 days
- Women who are visibly pregnant
- People whose other health conditions, or whose existing end-of-life care instructions, prevent them from having a general anaesthetic for the procedure
- People with a known terminal illness where survival beyond one year would not be expected
- People for whom a decision has already been made to withdraw active medical treatment or move to comfort-focused care only
- People where the trial doctor judges that joining the study could put them at risk or significantly affect their ability to take part
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
Contact this trial
Principal Investigator: Timothy Kleinig, Royal Adelaide Hospital/University of Adelaide
Phone: +61 3 9342 4424
Australian sites
John Hunter Hospital, Newcastle, New South Wales
+61 2 4921 3481
+61 2 4921 3481
Prince of Wales Hospital, Sydney, New South Wales
+61 2 9382 8891
+61 2 9382 8891
Royal Prince Alfred Hospital, Sydney, New South Wales
+61 2 9515 4596
+61 2 9515 4596
Westmead Hospital, Sydney, New South Wales
Liverpool Hospital, Sydney, New South Wales
+61 2 8738 7170
+61 2 8738 7170
The Royal Brisbane and Women's Hospital, Brisbane, Queensland
+61 7 3365 1111
+61 7 3365 1111
Princess Alexandra Hospital, Brisbane, Queensland
Gold Coast University Hospital, Southport, Queensland
+61 7 5687 6395
+61 7 5687 6395
The Royal Adelaide Hospital, Adelaide, South Australia
+61 8 7074 2900
+61 8 7074 2900
The Alfred Hospital, Melbourne, Victoria
+61 3 9903 8655
+61 3 9903 8655
The Austin Hospital, Melbourne, Victoria
+61 3 9496 4953
+61 3 9496 4953
Monash Medical Centre, Melbourne, Victoria
+61 3 9594 3836
+61 3 9594 3836
The Royal Melbourne Hospital, Parkville, Victoria
+61 3 9342 4424
+61 3 9342 4424
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Recruiting
Phase
Not Applicable
Sponsor
University of Melbourne
Registry
ClinicalTrials.gov
Start date
15 November 2020
Est. completion
1 December 2027
Where this trial is recruiting
🇦🇺 Australia
13 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Dichotomized Modified Rankin Scale Score 0-3 vs. 4-6 at 6 months post-onset (Adjusted)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.