- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04434807
Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment (EVACUATE)
October 22, 2021 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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- 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
- Name: Melbourne Brain Centre at the Royal Melbourne Hospital
- Phone Number: +61 3 9342 4424
- Email: info@thembc.org.au
Study Locations
-
-
New South Wales
-
Newcastle, New South Wales, Australia, 2305
- Recruiting
- John Hunter Hospital
-
Contact:
- Michelle Russell, RN
- Phone Number: +61 2 4921 3481
- Email: michelle.russell@health.nsw.gov.au
-
Principal Investigator:
- Carlos Garcia-Esperon
-
Sydney, New South Wales, Australia, 2170
- Recruiting
- Liverpool Hospital
-
Contact:
- Lisa Tran
- Phone Number: +61 2 8738 7170
- Email: Lisa.Tran@health.nsw.gov.au
-
Principal Investigator:
- Dennis Cordato
-
Sydney, New South Wales, Australia, 2031
- Not yet recruiting
- Prince of Wales Hospital
-
Contact:
- Fanfan Tian
- Phone Number: +61 2 9382 8891
- Email: huiqiao.tian@unsw.edu.au
-
Principal Investigator:
- Ken Butcher
-
Sydney, New South Wales, Australia, 2050
- Not yet recruiting
- Royal Prince Alfred Hospital
-
Contact:
- Kylie Tastula
- Phone Number: +61 2 9515 4596
- Email: Kylie.Tastula@health.nsw.gov.au
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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:
- Liam Maclachlan
- Phone Number: +61 7 3365 1111
- Email: liam.maclachlan@health.qld.gov.au
-
Principal Investigator:
- Hamish Alexander
-
Southport, Queensland, Australia, 4215
- Recruiting
- Gold Coast University Hospital
-
Contact:
- Victoria Cottam
- Phone Number: +61 7 5687 6395
- Email: Victoria.Cottam@health.qld.gov.au
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- Recruiting
- The Royal Adelaide Hospital
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Recruiting
- The Alfred Hospital
-
Contact:
- Andrea Moore, RN
- Phone Number: +61 3 9903 8655
- Email: andrea.moore@alfred.org.au
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Melbourne, Victoria, Australia, 3084
- Not yet recruiting
- The Austin Hospital
-
Contact:
- Dennis Young, RN
- Phone Number: +61 3 9496 4953
- Email: dennis.young@austin.org.au
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Melbourne, Victoria, Australia, 3168
- Not yet recruiting
- Monash Medical Centre
-
Contact:
- May Chong, RN
- Phone Number: +61 3 9594 3836
- Email: Mee.Chong@monashhealth.org
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Parkville, Victoria, Australia, 3050
- Recruiting
- The Royal Melbourne Hospital
-
-
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
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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
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
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
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
Investigators
- 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)
November 15, 2020
Primary Completion (ANTICIPATED)
December 1, 2025
Study Completion (ANTICIPATED)
December 1, 2026
Study Registration Dates
First Submitted
June 13, 2020
First Submitted That Met QC Criteria
June 13, 2020
First Posted (ACTUAL)
June 17, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 25, 2021
Last Update Submitted That Met QC Criteria
October 22, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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