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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
Neurosurgery performed via burr hole or minicraniotomy and using the Aurora surgiscope and evacuator (Integra Lifesciences)
John Hunter Hospital
Newcastle, New South Wales, Australia
RECRUITINGPrince of Wales Hospital
Sydney, New South Wales, Australia
NOT_YET_RECRUITINGRoyal Prince Alfred Hospital
Sydney, New South Wales, Australia
NOT_YET_RECRUITINGWestmead Hospital
Sydney, New South Wales, Australia
NOT_YET_RECRUITINGLiverpool Hospital
Sydney, New South Wales, Australia
RECRUITINGThe Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
RECRUITINGPrincess Alexandra Hospital
Brisbane, Queensland, Australia
NOT_YET_RECRUITINGGold Coast University Hospital
Southport, Queensland, Australia
RECRUITINGThe Royal Adelaide Hospital
Adelaide, South Australia, Australia
RECRUITINGThe Alfred Hospital
Melbourne, Victoria, Australia
RECRUITING...and 3 more locations
Dichotomized Modified Rankin Scale Score 0-3 vs. 4-6 at 6 months post-onset (Adjusted)
Modified Rankin Scale (mRS) 0-3 at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume.
Time frame: 6 months post-stroke
Dichotomized Modified Rankin Scale Score 0-2 or no change from baseline vs. 3-6 at 6 months post-onset (adjusted)
Modified Rankin Scale (mRS) 0-2 or no change from baseline at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume
Time frame: 6 months post-stroke
Ordinal analysis of Modified Rankin Scale Score at 6 months post-onset (adjusted)
Ordinal analysis of Modified Rankin Scale Score (merging mRS 5-6) at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume
Time frame: 6 months post-stroke
Utility-weighted analysis of Modified Rankin Scale Score at 6 months post-onset (adjusted)
Utility-weighted analysis of Modified Rankin Scale Score at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume
Time frame: 6 months post-stroke
Reduction in hematoma volume at 24 hours >70% or <15mL residual volume (adjusted)
Reduction in hematoma volume at 24 hours \>70% or \<15mL residual volume, adjusted for immediate pre-treatment ICH volume
Time frame: 24 hours post-randomization
Proportion of patients with early neurological improvement at 7 days (adjusted)
Proportion of patients with ≥8 point reduction in National Institutes of Health Stroke Scale (NIHSS) score or reaching 0-1 at 7 days (or at discharge if earlier) adjusted for baseline NIHSS and age
Time frame: 7 days post-stroke
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.