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NCT Number: NCT04434807

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Hunter Hospital, Newcastle, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Pre-stroke mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).
  • CTA or MRA is performed and does not show an underlying vascular lesion

Exclusion criteria

  • 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
  • Unreversible heparinization or anticoagulation. If reversing warfarin, INR should be ≤1.4 before procedure commences. Reversal of heparin by protamine, dabigatran by idarucizumab and rivaroxaban, apixaban and enoxaparin by andexanet (where available) is permitted. Unreversed anticoagulation with a last dose within 48 hours is an exclusion.
  • Recent (<12 hours) parenteral GPIIb/IIIa antagonist.
  • Recent (<1 hour) thrombolysis. If the ICH has occurred between 1 and 12 hours following thrombolysis, cryoprecipitate (1U per 10kg) and tranexamic acid must be administered prior to treatment.
  • Participation in any investigational study in the last 30 days
  • Pregnant women (clinically evident)
  • Co-morbidities or advance care directive preventing general anaesthesia for the procedure.
  • Known terminal illness such that the patients would not be expected to survive a year.
  • Planned withdrawal of care or comfort care measures.
  • Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

Treatment and study plan

Minimally invasive hematoma evacuation

Procedure

Neurosurgery performed via burr hole or minicraniotomy and using the Aurora surgiscope and evacuator (Integra Lifesciences)

Primary outcomes

  1. Dichotomized Modified Rankin Scale Score 0-3 vs. 4-6 at 6 months post-onset (Adjusted)

    Time frame: 6 months post-stroke

    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.

Secondary outcomes

  1. Dichotomized Modified Rankin Scale Score 0-2 or no change from baseline vs. 3-6 at 6 months post-onset (adjusted)

    Time frame: 6 months post-stroke

    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

  2. Ordinal analysis of Modified Rankin Scale Score at 6 months post-onset (adjusted)

    Time frame: 6 months post-stroke

    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

  3. Utility-weighted analysis of Modified Rankin Scale Score at 6 months post-onset (adjusted)

    Time frame: 6 months post-stroke

    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

  4. Reduction in hematoma volume at 24 hours >70% or <15mL residual volume (adjusted)

    Time frame: 24 hours post-randomization

    Reduction in hematoma volume at 24 hours >70% or <15mL residual volume, adjusted for immediate pre-treatment ICH volume

  5. Proportion of patients with early neurological improvement at 7 days (adjusted)

    Time frame: 7 days post-stroke

    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

Other outcomes

  1. Safety: Death due to any cause at 6 months (adjusted)

    Time frame: 6 months post-stroke

    Death due to any cause at 6 months, adjusted for age, baseline GCS, immediate pre-treatment ICH volume and immediate pre-treatment IVH volume.

  2. Safety: Hematoma growth or reaccumulation at 24 hours

    Time frame: 24 hours post-randomization

    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.

  3. Intermediate outcome measure (primary outcome measure for Phase 2b component): Reduction in hematoma volume at 24 hours >70% or <15mL residual volume (adjusted)

    Time frame: 24 hours post-randomization

    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

  4. Patient Reported Outcomes Measurement Information System (PROMIS10)

    Time frame: 6 and 12 months post-stroke

  5. Modified Rankin Scale (mRS) 0-2, 0-3, ordinal and utility-weighted analysis at 12 months

    Time frame: 12 months post-stroke

  6. Assessment of Quality of Life (EQ5D) at 12 months

    Time frame: 12 months post-stroke

    Assessment of Quality of Life (EQ5D) at 12 months (mapped to mRS at baseline)

  7. Length of stay in intensive care unit, acute hospital, acute hospital and rehabilitation

    Time frame: 6 months post-stroke

  8. Home time - time spent at home in the first 6 months

    Time frame: 6 months post-stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Melbourne Brain Centre at the Royal Melbourne Hospital

CONTACT

[email protected]

+61 3 9342 4424

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Registry information

Official study title

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

Acronym: EVACUATE

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Jun 17, 2020
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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