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

October 24, 2025 updated by: Bruce Campbell, University of Melbourne

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Melbourne Brain Centre at the Royal Melbourne Hospital
  • Phone Number: +61 3 9342 4424
  • Email: info@thembc.org.au

Study Locations

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2305
        • Recruiting
        • John Hunter Hospital
        • Contact:
        • Principal Investigator:
          • Carlos Garcia-Esperon
      • Sydney, New South Wales, Australia, 2170
        • Recruiting
        • Liverpool Hospital
        • Contact:
        • Principal Investigator:
          • Dennis Cordato
      • Sydney, New South Wales, Australia, 2031
        • Not yet recruiting
        • Prince of Wales Hospital
        • Contact:
        • Principal Investigator:
          • Ken Butcher
      • Sydney, New South Wales, Australia, 2050
        • Not yet recruiting
        • Royal Prince Alfred Hospital
        • Contact:
        • Principal Investigator:
          • John Worthington
      • Sydney, New South Wales, Australia, 2145
        • Not yet recruiting
        • Westmead Hospital
        • Principal Investigator:
          • Mark Dexter
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Not yet recruiting
        • Princess Alexandra Hospital
        • Principal Investigator:
          • Jeff Webster
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • The Royal Brisbane and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Hamish Alexander
      • Southport, Queensland, Australia, 4215
        • Recruiting
        • Gold Coast University Hospital
        • Contact:
        • Principal Investigator:
          • Peter Bailey
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • The Royal Adelaide Hospital
        • Principal Investigator:
          • Timothy Kleinig
        • Contact:
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
        • Principal Investigator:
          • Geoffrey Cloud
      • Melbourne, Victoria, Australia, 3084
        • Not yet recruiting
        • The Austin Hospital
        • Contact:
        • Principal Investigator:
          • Vincent Thijs
      • Melbourne, Victoria, Australia, 3168
        • Not yet recruiting
        • Monash Medical Centre
        • Contact:
        • Principal Investigator:
          • Henry Ma
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • The Royal Melbourne Hospital
        • Principal Investigator:
          • Bruce Campbell
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months post-stroke

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 months post-stroke
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
6 months post-stroke
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
6 months post-stroke
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
24 hours post-randomization
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
7 days post-stroke

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 months post-stroke
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.
24 hours post-randomization
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
24 hours post-randomization
Patient Reported Outcomes Measurement Information System (PROMIS10)
Time Frame: 6 and 12 months post-stroke
6 and 12 months post-stroke
Modified Rankin Scale (mRS) 0-2, 0-3, ordinal and utility-weighted analysis at 12 months
Time Frame: 12 months post-stroke
12 months post-stroke
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)
12 months post-stroke
Length of stay in intensive care unit, acute hospital, acute hospital and rehabilitation
Time Frame: 6 months post-stroke
6 months post-stroke
Home time - time spent at home in the first 6 months
Time Frame: 6 months post-stroke
6 months post-stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Melbourne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MBC2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

2 years after the publication of the primary manuscript

IPD Sharing Access Criteria

Qualified investigators can access data after submission of a project proposal that has been approved by the VISTA-ICH steering committee.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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