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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04434807
Other study ID # MBC2001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2020
Est. completion date December 2026

Study information

Verified date October 2021
Source University of Melbourne
Contact Melbourne Brain Centre at the Royal Melbourne Hospital
Phone +61 3 9342 4424
Email info@thembc.org.au
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Australia The Royal Adelaide Hospital Adelaide South Australia
Australia Princess Alexandra Hospital Brisbane Queensland
Australia The Royal Brisbane and Women's Hospital Brisbane Queensland
Australia Monash Medical Centre Melbourne Victoria
Australia The Alfred Hospital Melbourne Victoria
Australia The Austin Hospital Melbourne Victoria
Australia John Hunter Hospital Newcastle New South Wales
Australia The Royal Melbourne Hospital Parkville Victoria
Australia Gold Coast University Hospital Southport Queensland
Australia Liverpool Hospital Sydney New South Wales
Australia Prince of Wales Hospital Sydney New South Wales
Australia Royal Prince Alfred Hospital Sydney New South Wales
Australia Westmead Hospital Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety: Death due to any cause at 6 months (adjusted) 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
Other Safety: Hematoma growth or reaccumulation at 24 hours 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
Other Intermediate outcome measure (primary outcome measure for Phase 2b component): Reduction in hematoma volume at 24 hours >70% or <15mL residual volume (adjusted) 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
Other Patient Reported Outcomes Measurement Information System (PROMIS10) 6 and 12 months post-stroke
Other Modified Rankin Scale (mRS) 0-2, 0-3, ordinal and utility-weighted analysis at 12 months 12 months post-stroke
Other Assessment of Quality of Life (EQ5D) at 12 months Assessment of Quality of Life (EQ5D) at 12 months (mapped to mRS at baseline) 12 months post-stroke
Other Length of stay in intensive care unit, acute hospital, acute hospital and rehabilitation 6 months post-stroke
Other Home time - time spent at home in the first 6 months 6 months post-stroke
Primary 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. 6 months post-stroke
Secondary 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 6 months post-stroke
Secondary 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 6 months post-stroke
Secondary 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 6 months post-stroke
Secondary 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 24 hours post-randomization
Secondary 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 7 days post-stroke
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