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

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ClinicalTrials.gov Identifier: NCT04434807
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
Bruce Campbell, University of Melbourne

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Intra Cerebral Hemorrhage Stroke Procedure: Minimally invasive hematoma evacuation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will receive either minimally invasive hematoma evacuation or standard medical therapy
Masking: Single (Outcomes Assessor)
Masking Description: The primary outcome of Modified Rankin scale (mRS) and secondary outcomes including National Institutes of Health Stroke Scale (NIHSS) are assessed by a blinded clinician.
Primary Purpose: Treatment
Official Title: Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment (EVACUATE)
Actual Study Start Date : November 15, 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: Minimally invasive hematoma evacuation
Patients randomized to minimally invasive hematoma evacuation will have neurosurgery followed by standard medical therapy in a stroke care unit or intensive care unit, as appropriate to the patients clinical condition.
 Procedure: Minimally invasive hematoma evacuation
Neurosurgery performed via burr hole or minicraniotomy and using the Aurora surgiscope and evacuator (Integra Lifesciences)
No Intervention: Standard care (medical therapy)
Patients randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage in a stroke care unit or intensive care unit, as appropriate to the patients clinical condition, with no planned surgical intervention.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with an acute supratentorial intracerebral hemorrhage (ICH) ≥20mL in volume
  2. Age ≥18 years
  3. 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
  4. Moderate neurological deficit (NIHSS≥6)
  5. Pre-stroke mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).
  6. CTA or MRA is performed and does not show an underlying vascular lesion

Exclusion Criteria:

  1. Brainstem ICH
  2. 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.
  3. Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency (in liver disease, INR>1.4).
  4. Platelet count <75,000
  5. 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.
  6. Recent (<12 hours) parenteral GPIIb/IIIa antagonist.
  7. 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.
  8. Participation in any investigational study in the last 30 days
  9. Pregnant women (clinically evident)
  10. Co-morbidities or advance care directive preventing general anaesthesia for the procedure.
  11. Known terminal illness such that the patients would not be expected to survive a year.
  12. Planned withdrawal of care or comfort care measures.
  13. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04434807


Contacts
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Contact: Melbourne Brain Centre at the Royal Melbourne Hospital +61 3 9342 4424 info@thembc.org.au

Locations
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Australia, New South Wales
John Hunter Hospital Recruiting
Newcastle, New South Wales, Australia, 2305
Contact: Michelle Russell, RN    +61 2 4921 3481    michelle.russell@health.nsw.gov.au   
Principal Investigator: Carlos Garcia-Esperon         
Prince of Wales Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2031
Contact: Fanfan Tian    +61 2 9382 8891    huiqiao.tian@unsw.edu.au   
Principal Investigator: Ken Butcher         
Royal Prince Alfred Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2050
Contact: Kylie Tastula    +61 2 9515 4596    Kylie.Tastula@health.nsw.gov.au   
Principal Investigator: John Worthington         
Westmead Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2145
Principal Investigator: Mark Dexter         
Liverpool Hospital Recruiting
Sydney, New South Wales, Australia, 2170
Contact: Lisa Tran    +61 2 8738 7170    Lisa.Tran@health.nsw.gov.au   
Principal Investigator: Dennis Cordato         
Australia, Queensland
The Royal Brisbane and Women's Hospital Recruiting
Brisbane, Queensland, Australia, 4029
Contact: Liam Maclachlan    +61 7 3365 1111    liam.maclachlan@health.qld.gov.au   
Principal Investigator: Hamish Alexander         
Princess Alexandra Hospital Not yet recruiting
Brisbane, Queensland, Australia, 4102
Principal Investigator: Jeff Webster         
Gold Coast University Hospital Recruiting
Southport, Queensland, Australia, 4215
Contact: Victoria Cottam    +61 7 5687 6395    Victoria.Cottam@health.qld.gov.au   
Principal Investigator: Peter Bailey         
Australia, South Australia
The Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Jennifer Cranefield, RN    +61 8 7074 2900    jennifer.cranefield@sa.gov.au   
Principal Investigator: Timothy Kleinig         
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Andrea Moore, RN    +61 3 9903 8655    andrea.moore@alfred.org.au   
Principal Investigator: Geoffrey Cloud         
The Austin Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3084
Contact: Dennis Young, RN    +61 3 9496 4953    dennis.young@austin.org.au   
Principal Investigator: Vincent Thijs         
Monash Medical Centre Not yet recruiting
Melbourne, Victoria, Australia, 3168
Contact: May Chong, RN    +61 3 9594 3836    Mee.Chong@monashhealth.org   
Principal Investigator: Henry Ma         
The Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact: Amy McDonald, RN    +61 3 9342 4424    amy.mcdonald@mh.org.au   
Principal Investigator: Bruce Campbell         
Sponsors and Collaborators
University of Melbourne
Investigators
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Principal Investigator: Timothy Kleinig Royal Adelaide Hospital/University of Adelaide
Principal Investigator: Amal Abou-Hamden Royal Adelaide Hospital/University of Adelaide
Principal Investigator: John Laidlaw Royal Melbourne Hospital/University of Melbourne
Principal Investigator: J Mocco Icahn School of Medicine, Mt Sinai Hospital, New York
Principal Investigator: Christopher Kellner Icahn School of Medicine, Mt Sinai Hospital, New York
Principal Investigator: Stephen Davis Royal Melbourne Hospital/University of Melbourne
Principal Investigator: Bruce Campbell Royal Melbourne Hospital/University of Melbourne
More Information
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Responsible Party: Bruce Campbell, Professorial Fellow, Department of Medicine, Royal Melbourne Hospital, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
ClinicalTrials.gov Identifier: NCT04434807    
Other Study ID Numbers: MBC2001
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient data will be uploaded to the Virtual Stroke Trials Archive (http://www.virtualtrialsarchives.org/vista/) 2 years after the publication of the primary manuscript. Qualified investigators can access data after submission of a project proposal that has been approved by the VISTA-ICH steering committee.
Time Frame: 2 years after the publication of the primary manuscript
Access Criteria: Qualified investigators can access data after submission of a project proposal that has been approved by the VISTA-ICH steering committee.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bruce Campbell, University of Melbourne:
neurosurgery
minimally invasive
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases