Status:
RECRUITING
Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment
Lead Sponsor:
University of Melbourne
Conditions:
Intra Cerebral Hemorrhage
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04434807
Start Date
November 15 2020
End Date
December 1 2028
Last Update
October 28 2025
Active Locations (13)
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1
John Hunter Hospital
Newcastle, New South Wales, Australia, 2305
2
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
3
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
4
Westmead Hospital
Sydney, New South Wales, Australia, 2145