Condition: Intra Cerebral Hemorrhage · Stroke · Sponsor: University of Melbourne
A randomized controlled trial of ultra-early, minimally invasive, hematoma evacuation versus standard care within 8 hours of intracerebral hemorrhage. Patients presenting to the emergency department with stroke due to supratentorial, spontaneous intracerebral hemorrhage \>20mL volume will be assessed to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomized 50:50 using central computerized allocation to minimally invasive hematoma evacuation using the Aurora surgiscope and evacuator (Integra Lifesciences) versus standard medical therapy. The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design with seamless phase 2b-3 transition if the intermediate endpoint (successful hematoma evacuation) is met in analysis of the first 52 patients. Adaptive sample size re-estimation (Mehta and Pocock) will be performed when 160 patients have completed 6 month follow-up (minimum sample size 240, maximum sample size 434).
This description comes directly from the study's public registry record.
Melbourne Brain Centre at the Royal Melbourne Hospital · +61 3 9342 4424 · info@thembc.org.au
Always discuss trial participation with your own doctor first.
| John Hunter Hospital | Newcastle, New South Wales, Australia | Recruiting |
| Prince of Wales Hospital | Sydney, New South Wales, Australia | Not Yet Recruiting |
| Royal Prince Alfred Hospital | Sydney, New South Wales, Australia | Not Yet Recruiting |
| Westmead Hospital | Sydney, New South Wales, Australia | Not Yet Recruiting |
| Liverpool Hospital | Sydney, New South Wales, Australia | Recruiting |
| The Royal Brisbane and Women's Hospital | Brisbane, Queensland, Australia | Recruiting |
| Princess Alexandra Hospital | Brisbane, Queensland, Australia | Not Yet Recruiting |
| Gold Coast University Hospital | Southport, Queensland, Australia | Recruiting |
| The Royal Adelaide Hospital | Adelaide, South Australia, Australia | Recruiting |
| The Alfred Hospital | Melbourne, Victoria, Australia | Recruiting |
| The Austin Hospital | Melbourne, Victoria, Australia | Not Yet Recruiting |
| Monash Medical Centre | Melbourne, Victoria, Australia | Not Yet Recruiting |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04434807