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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04434807
Ethics application status
Date submitted
13/06/2020
Date registered
17/06/2020
Date last updated
25/06/2024

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)
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)
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)
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)
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)
Timepoint [4] 0 0
24 hours post-randomization
Secondary outcome [5] 0 0
Proportion of patients with early neurological improvement at 7 days (adjusted)
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
Sex
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital - Sydney
Recruitment hospital [5] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [6] 0 0
The Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [8] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [9] 0 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [11] 0 0
The Austin Hospital - Melbourne
Recruitment hospital [12] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [13] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2305 - Newcastle
Recruitment postcode(s) [2] 0 0
2031 - Sydney
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Sydney
Recruitment postcode(s) [5] 0 0
2170 - Sydney
Recruitment postcode(s) [6] 0 0
4029 - Brisbane
Recruitment postcode(s) [7] 0 0
4102 - Brisbane
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
3084 - Melbourne
Recruitment postcode(s) [12] 0 0
3168 - Melbourne
Recruitment postcode(s) [13] 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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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