Actively Recruiting
Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment
Led by University of Melbourne · Updated on 2025-10-28
240
Participants Needed
13
Research Sites
419 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with an acute supratentorial intracerebral hemorrhage of 20mL or more in volume
- Age 18 years or older
- Surgery can start within 8 hours of symptom onset or within 8 hours of clinical deterioration for smaller hemorrhages
- Moderate neurological deficit with NIHSS score of 6 or higher
- Pre-stroke modified Rankin Scale of 3 or less (independent or minor assistance)
- CTA or MRA imaging shows no underlying vascular lesion
You will not qualify if you...
- Brainstem intracerebral hemorrhage
- Hemorrhage due to trauma where brain injury is mainly from trauma effects
- Hereditary or acquired bleeding disorders or coagulation factor deficiency with INR greater than 1.4
- Platelet count less than 75,000
- Unreversible anticoagulation or heparinization; warfarin reversal required before surgery with INR 1.4 or less
- Recent use of parenteral GPIIb/IIIa antagonist within 12 hours
- Recent thrombolysis within 1 hour; if between 1 and 12 hours, specific treatments must be given before surgery
- Participation in another clinical trial within the last 30 days
- Pregnant women with clinically evident pregnancy
- Co-morbidities or advance care directives preventing general anesthesia
- Known terminal illness with expected survival less than one year
- Planned withdrawal of care or comfort measures
- Any condition that may pose risk or affect study participation according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
John Hunter Hospital
Newcastle, New South Wales, Australia, 2305
Actively Recruiting
2
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
Not Yet Recruiting
3
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Not Yet Recruiting
4
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Not Yet Recruiting
5
Liverpool Hospital
Sydney, New South Wales, Australia, 2170
Actively Recruiting
6
The Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Actively Recruiting
7
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Not Yet Recruiting
8
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
9
The Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
10
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
11
The Austin Hospital
Melbourne, Victoria, Australia, 3084
Not Yet Recruiting
12
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Not Yet Recruiting
13
The Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Actively Recruiting
Research Team
M
Melbourne Brain Centre at the Royal Melbourne Hospital
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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