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Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment
Sponsor: University of Melbourne
Summary
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).
Official title: Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment (EVACUATE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2020-11-15
Completion Date
2028-12
Last Updated
2025-10-28
Healthy Volunteers
No
Conditions
Interventions
Minimally invasive hematoma evacuation
Neurosurgery performed via burr hole or minicraniotomy and using the Aurora surgiscope and evacuator (Integra Lifesciences)
Locations (13)
John Hunter Hospital
Newcastle, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Liverpool Hospital
Sydney, New South Wales, Australia
The Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
The Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
The Austin Hospital
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia