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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04434807




Registration number
NCT04434807
Ethics application status
Date submitted
13/06/2020
Date registered
17/06/2020
Date last updated
17/06/2020

Titles & IDs
Public title
Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment
Scientific title
Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment (EVACUATE)
Secondary ID [1] 0 0
MBC2001
Universal Trial Number (UTN)
Trial acronym
EVACUATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intra Cerebral Hemorrhage 0 0
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Minimally invasive hematoma evacuation

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.

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.


Treatment: Surgery: Minimally invasive hematoma evacuation
Neurosurgery performed via burr hole or minicraniotomy and using the Aurora surgiscope and evacuator (Integra Lifesciences)

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months post-stroke
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
6 months post-stroke
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
6 months post-stroke
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
6 months post-stroke
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
24 hours post-randomization
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
7 days post-stroke

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT04434807
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Timothy Kleinig
Address 0 0
Royal Adelaide Hospital/University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Melbourne Brain Centre at the Royal Melbourne Hospital
Address 0 0
Country 0 0
Phone 0 0
+61 3 9342 4424
Fax 0 0
Email 0 0
info@thembc.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04434807