Minimally invasive treatment for brain hemorrhage compared to standard care

Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment (EVACUATE)

This study is testing a new, less invasive treatment for brain bleeding to see if it works better than standard care for patients who arrive at the emergency room with a significant hemorrhage.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Melbourne (Academic / other)
• Drugs / interventions: idarucizumab
• Locations: 13 sites (Newcastle, New South Wales and 12 other locations)
• Trial ID: NCT04434807 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of ultra-early, minimally invasive hematoma evacuation compared to standard medical treatment for patients with supratentorial intracerebral hemorrhage. Patients presenting to the emergency department with a hemorrhage volume greater than 20mL will be randomly assigned to either the new treatment or standard care within 8 hours of symptom onset. The study employs a randomized, open-label design with a focus on successful hematoma evacuation as an intermediate endpoint. The trial aims to gather data from at least 240 patients to assess the outcomes of the interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a significant intracerebral hemorrhage of at least 20mL and moderate neurological deficits.

Not a fit: Patients with brainstem hemorrhages or those whose hemorrhage is secondary to trauma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients suffering from intracerebral hemorrhage.

How similar studies have performed: Other studies have shown promise with minimally invasive techniques for similar conditions, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Newcastle, New South Wales and 12 other locations

• John Hunter Hospital — Newcastle, New South Wales, Australia (Recruiting)
• Prince of Wales Hospital — Sydney, New South Wales, Australia (Not_yet_recruiting)
• Royal Prince Alfred Hospital — Sydney, New South Wales, Australia (Not_yet_recruiting)
• Westmead Hospital — Sydney, New South Wales, Australia (Not_yet_recruiting)
• Liverpool Hospital — Sydney, New South Wales, Australia (Recruiting)
• The Royal Brisbane and Women's Hospital — Brisbane, Queensland, Australia (Recruiting)
• Princess Alexandra Hospital — Brisbane, Queensland, Australia (Not_yet_recruiting)
• Gold Coast University Hospital — Southport, Queensland, Australia (Recruiting)
• The Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
• The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
• The Austin Hospital — Melbourne, Victoria, Australia (Not_yet_recruiting)
• Monash Medical Centre — Melbourne, Victoria, Australia (Not_yet_recruiting)
• The Royal Melbourne Hospital — Parkville, Victoria, Australia (Recruiting)

Study contacts

• Principal investigator: Timothy Kleinig — Royal Adelaide Hospital/University of Adelaide
• Study coordinator: Melbourne Brain Centre at the Royal Melbourne Hospital

Conditions Intra Cerebral Hemorrhage; Stroke; neurosurgery; minimally invasive