Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Melbourne
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with an acute supratentorial intracerebral hemorrhage (ICH) ≥20mL in volume
Age ≥18 years
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
Moderate neurological deficit (NIHSS≥6)
Disqualifiers
Brainstem ICH
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.
Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency (in liver disease, INR>1.4).
Platelet count <75,000
Trial design
Design model
Parallel
Treatments tested in this trial
Minimally invasive hematoma evacuation
Procedure/SurgeryNeurosurgery performed via burr hole or minicraniotomy and using the Aurora surgiscope and evacuator (Integra Lifesciences)
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Minimally invasive hematoma evacuationExperimental treatment 1 intervention
Group B: Standard care (medical therapy)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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-strokeSecondary outcomes
1
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-stroke2
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-stroke3
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-stroke4
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-randomizationOther outcomes
1
Safety: Death due to any cause at 6 months (adjusted)
Death due to any cause at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume.
Time frame
6 months post-stroke2
Safety: Hematoma growth or reaccumulation at 24 hours
Hematoma growth or reaccumulation defined as \>33% or \>6mL increased volume between baseline and 24 hour scans (or in the intervention arm a hematoma volume on the follow-up scan exceeding the immediate pre-treatment volume), adjusted for the pre-treatment ICH volume.
Time frame
24 hours post-randomization3
Intermediate outcome measure (primary outcome measure for Phase 2b component): Reduction in hematoma volume at 24 hours >70% or <15mL residual volume (adjusted)
Intermediate outcome measure (primary outcome measure for the Phase 2b component to be analysed for the first 52 patients): Reduction in hematoma volume at 24 hours \>70% or \<15mL residual volume, adjusted for immediate pre-treatment ICH volume
Time frame
24 hours post-randomization4
Patient Reported Outcomes Measurement Information System (PROMIS10)
Time frame
6 and 12 months post-strokeSponsors and contacts
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Source ClinicalTrials.gov