AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment

RecruitingNAAges 18 Years - anyAllUniversity of Melbourne
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients with an acute supratentorial intracerebral hemorrhage (ICH) ≥20mL in volume 2. Age ≥18 years 3. Surgery can commence within 8 hours of symptom onset (the time the patient was last known to be well) or, in patients with wake-up onset, within 8 hours of the time the patient awoke with symptoms. Patients presenting with small ICH (volume \<20mL) with clinical deterioration judged due to ICH hematoma expansion meeting volume criteria may be randomized if surgery can commence within 8 hours of clinical deterioration 4. Moderate neurological deficit (NIHSS≥6) 5. Pre-stroke mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week). 6. CTA or MRA is performed and does not show an underlying vascular lesion Exclusion Criteria: 1. Brainstem ICH 2. ICH secondary to trauma, where brain injury is judged more likely to be due to the broad effects of trauma rather than the focal ICH. 3. Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency (in liver disease, INR\>1.4). 4. Platelet count \<75,000 5. Unreversible heparinization or anticoagulation. If reversing warfarin, INR should be ≤1.4 before procedure commences. Reversal of heparin by protamine, dabigatran by idarucizumab and rivaroxaban, apixaban and enoxaparin by andexanet (where available) is permitted. Unreversed anticoagulation with a last dose within 48 hours is an exclusion. 6. Recent (\<12 hours) parenteral GPIIb/IIIa antagonist. 7. Recent (\<1 hour) thrombolysis. If the ICH has occurred between 1 and 12 hours following thrombolysis, cryoprecipitate (1U per 10kg) and tranexamic acid must be administered prior to treatment. 8. Participation in any investigational study in the last 30 days 9. Pregnant women (clinically evident) 10. Co-morbidities or advance care directive preventing general anaesthesia for the procedure. 11. Known terminal illness such that the patients would not be expected to survive a year. 12. Planned withdrawal of care or comfort care measures. 13. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
💊

What it tests

  • Minimally invasive hematoma evacuation
📍

Where

13 sites
John Hunter Hospital
Newcastle, Australia
Prince of Wales Hospital
Sydney, Australia
Royal Prince Alfred Hospital
Sydney, Australia
Westmead Hospital
Sydney, Australia
Liverpool Hospital
Sydney, Australia
The Royal Brisbane and Women's Hospital
Brisbane, Australia
Princess Alexandra Hospital
Brisbane, Australia
Gold Coast University Hospital
Southport, Australia

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy