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RECRUITING
NCT04434807
NA

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

Sponsor: University of Melbourne

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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