Intra Cerebral HemorrhageEVACUATENCT04434807
Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment
A study testing Minimally invasive hematoma evacuation in people with Intra Cerebral Hemorrhage and Stroke, run by University of Melbourne at 13 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra Cerebral Hemorrhage, Stroke
- What is being tested?
- Minimally invasive hematoma evacuation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 13 sitesAustralia
- Study dates
- 15 Nov 2020to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Australia13 sites, 13 recruiting
- Recruiting
The Royal Adelaide Hospital
Adelaide, South Australia, 5000
Jennifer Cranefield, RN, +61 8 7074 2900, jennifer.cranefield@sa.gov.au
Timothy Kleinig
- Recruiting
The Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Liam Maclachlan, +61 7 3365 1111, liam.maclachlan@health.qld.gov.au
Hamish Alexander
- Not yet recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Jeff Webster
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Andrea Moore, RN, +61 3 9903 8655, andrea.moore@alfred.org.au
Geoffrey Cloud
- Not yet recruiting
The Austin Hospital
Melbourne, Victoria, 3084
Dennis Young, RN, +61 3 9496 4953, dennis.young@austin.org.au
Vincent Thijs
- Not yet recruiting
Monash Medical Centre
Melbourne, Victoria, 3168
May Chong, RN, +61 3 9594 3836, Mee.Chong@monashhealth.org
Henry Ma
- Recruiting
John Hunter Hospital
Newcastle, New South Wales, 2305
Michelle Russell, RN, +61 2 4921 3481, michelle.russell@health.nsw.gov.au
Carlos Garcia-Esperon
- Recruiting
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Amy McDonald, RN, +61 3 9342 4424, amy.mcdonald@mh.org.au
Bruce Campbell
- Recruiting
Gold Coast University Hospital
Southport, Queensland, 4215
Victoria Cottam, +61 7 5687 6395, Victoria.Cottam@health.qld.gov.au
Peter Bailey
- Not yet recruiting
Prince of Wales Hospital
Sydney, New South Wales, 2031
Fanfan Tian, +61 2 9382 8891, huiqiao.tian@unsw.edu.au
Ken Butcher
- Not yet recruiting
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Kylie Tastula, +61 2 9515 4596, Kylie.Tastula@health.nsw.gov.au
John Worthington
- Not yet recruiting
Westmead Hospital
Sydney, New South Wales, 2145
Mark Dexter
- Recruiting
Liverpool Hospital
Sydney, New South Wales, 2170
Lisa Tran, +61 2 8738 7170, Lisa.Tran@health.nsw.gov.au
Dennis Cordato
About this study
Official title: 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).
- Conditions
- Intra Cerebral Hemorrhage, Stroke
- Being tested
- Minimally invasive hematoma evacuation
- Keywords
- neurosurgery, minimally invasive
- Medical subject headings
- Cerebral Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive hematoma evacuationProcedure or surgery
Neurosurgery performed via burr hole or minicraniotomy and using the Aurora surgiscope and evacuator (Integra Lifesciences)
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive hematoma evacuation | Experimental | 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. Receives: Procedure: Minimally invasive hematoma evacuation |
| Standard care (medical therapy) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-stroke
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 days post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start15 Nov 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra Cerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will receive either minimally invasive hematoma evacuation or standard medical therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Campbell, University of Melbourne
- Investigators
- Timothy Kleinig, Principal investigator, Royal Adelaide Hospital/University of AdelaideAmal Abou-Hamden, Principal investigator, Royal Adelaide Hospital/University of AdelaideJohn Laidlaw, Principal investigator, Royal Melbourne Hospital/University of MelbourneJ Mocco, Principal investigator, Icahn School of Medicine, Mt Sinai Hospital, New YorkChristopher Kellner, Principal investigator, Icahn School of Medicine, Mt Sinai Hospital, New YorkStephen Davis, Principal investigator, Royal Melbourne Hospital/University of MelbourneBruce Campbell, Principal investigator, Royal Melbourne Hospital/University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434807
- Sponsor's protocol ID
- MBC2001
- Acronym
- EVACUATE
- Status last verified
- Oct 2025
- First submitted
- 13 Jun 2020
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment (EVACUATE)
- ClinicalTrials.gov ID
- NCT04434807
- Acronym / sponsor ID
- EVACUATE / MBC2001
- Conditions
- Intra Cerebral Hemorrhage, Stroke
- Keywords
- neurosurgery, minimally invasive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will receive either minimally invasive hematoma evacuation or standard medical therapy
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive hematoma evacuation | Experimental | Procedure: Minimally invasive hematoma evacuationPatients 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. |
| Standard care (medical therapy) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive hematoma evacuationNeurosurgery performed via burr hole or minicraniotomy and using the Aurora surgiscope and evacuator (Integra Lifesciences) | Procedure or surgery | Minimally invasive hematoma evacuation |
Primary outcome
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.
5 secondary outcomes
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
Ordinal 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 post-onset (adjusted)
Time frame: 6 months post-stroke
Reduction in hematoma volume at 24 hours >70% or <15mL residual volume (adjusted)
Time frame: 24 hours post-randomization
Proportion of patients with early neurological improvement at 7 days (adjusted)
Time frame: 7 days post-stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy Kleinig principal investigator
Royal Adelaide Hospital/University of Adelaide
Amal Abou-Hamden principal investigator
Royal Adelaide Hospital/University of Adelaide
John Laidlaw principal investigator
Royal Melbourne Hospital/University of Melbourne
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive hematoma evacuation in people with Intra Cerebral Hemorrhage and Stroke, run by University of Melbourne at 13 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melbourne Brain Centre at the Royal Melbourne Hospital (+61 3 9342 4424, info@thembc.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dichotomized Modified Rankin Scale Score 0-3 vs. 4-6 at 6 months post-onset (Adjusted) (time frame: 6 months post-stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.