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Search / Trial NCT04434807

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

Launched by UNIVERSITY OF MELBOURNE · Jun 13, 2020

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Neurosurgery Minimally Invasive

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients who have experienced a specific type of stroke called intracerebral hemorrhage, which happens when there is bleeding in the brain. The trial compares an ultra-early, minimally invasive surgery to remove the blood clot against standard medical care, both of which must be done within 8 hours of the stroke symptoms starting. Patients aged 18 and older, with a significant amount of bleeding (more than 20 mL), and certain neurological conditions may be eligible to participate. To join the study, patients must consent to be randomly assigned to either the new surgical method or the standard treatment.

Participants in this trial can expect close monitoring and care, as well as follow-ups over six months to see how well they recover. It's important to note that certain health conditions, like severe bleeding disorders or recent treatments, may prevent someone from being eligible. This trial is currently recruiting, and its goal is to see if the new surgical method leads to better outcomes for patients after a hemorrhagic stroke.

Gender

ALL

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.

About University Of Melbourne

The University of Melbourne, a leading research institution in Australia, is dedicated to advancing medical science and improving healthcare outcomes through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses the expertise of its world-class faculty and state-of-the-art facilities to conduct rigorous research across various medical fields. Committed to ethical standards and participant safety, the University of Melbourne aims to translate research findings into practical applications, ultimately enhancing patient care and contributing to global health advancements.

Locations

Brisbane, Queensland, Australia

Parkville, Victoria, Australia

Melbourne, Victoria, Australia

Sydney, New South Wales, Australia

Melbourne, Victoria, Australia

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

Sydney, New South Wales, Australia

Newcastle, New South Wales, Australia

Southport, Queensland, Australia

Melbourne, Victoria, Australia

Adelaide, South Australia, Australia

Brisbane, Queensland, Australia

Sydney, New South Wales, Australia

Patients applied

0 patients applied

Trial Officials

Timothy Kleinig

Principal Investigator

Royal Adelaide Hospital/University of Adelaide

Amal Abou-Hamden

Principal Investigator

Royal Adelaide Hospital/University of Adelaide

John Laidlaw

Principal Investigator

Royal Melbourne Hospital/University of Melbourne

J Mocco

Principal Investigator

Icahn School of Medicine, Mt Sinai Hospital, New York

Christopher Kellner

Principal Investigator

Icahn School of Medicine, Mt Sinai Hospital, New York

Stephen Davis

Principal Investigator

Royal Melbourne Hospital/University of Melbourne

Bruce Campbell

Principal Investigator

Royal Melbourne Hospital/University of Melbourne

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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