Minimally invasive treatment for brain hemorrhage compared to standard care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• John Hunter Hospital
  Newcastle, New South Wales, Australia Recruiting
• Liverpool Hospital
  Sydney, New South Wales, Australia Recruiting
• The Royal Brisbane and Women's Hospital
  Brisbane, Queensland, Australia 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

Study contacts

• Principal investigator: Timothy Kleinig — Royal Adelaide Hospital/University of Adelaide
• Study coordinator: Melbourne Brain Centre at the Royal Melbourne Hospital
• Email: info@thembc.org.au
• Phone: +61 3 9342 4424

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.