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

NCT04434807 | Recruiting DMC FDA Device

• 1 other identifier: MBC2001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 13

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 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).

Conditions

Intra Cerebral Hemorrhage; Stroke

Keywords

neurosurgery; minimally invasive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Dichotomized Modified Rankin Scale Score 0-2 or no change from baseline vs. 3-6 at 6 months post-onset (adjusted)

  6 months post-stroke

• Ordinal analysis of Modified Rankin Scale Score at 6 months post-onset (adjusted)

  6 months post-stroke

• Utility-weighted analysis of Modified Rankin Scale Score at 6 months post-onset (adjusted)

  6 months post-stroke

• Reduction in hematoma volume at 24 hours >70% or <15mL residual volume (adjusted)

  24 hours post-randomization

• Proportion of patients with early neurological improvement at 7 days (adjusted)

  7 days post-stroke

Other Outcomes (8)

• Safety: Death due to any cause at 6 months (adjusted)

  6 months post-stroke

• Safety: Hematoma growth or reaccumulation at 24 hours

  24 hours post-randomization

• Intermediate outcome measure (primary outcome measure for Phase 2b component): Reduction in hematoma volume at 24 hours >70% or <15mL residual volume (adjusted)

  24 hours post-randomization

Study Arms (2)

Minimally invasive hematoma evacuation

EXPERIMENTAL

Patients randomized to minimally invasive hematoma evacuation will have neurosurgery followed by standard medical therapy in a stroke care unit or intensive care unit, as appropriate to the patients clinical condition.

Procedure: Minimally invasive hematoma evacuation

Standard care (medical therapy)

NO INTERVENTION

Patients randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage in a stroke care unit or intensive care unit, as appropriate to the patients clinical condition, with no planned surgical intervention.

Interventions

Minimally invasive hematoma evacuation PROCEDURE

Neurosurgery performed via burr hole or minicraniotomy and using the Aurora surgiscope and evacuator (Integra Lifesciences)

Minimally invasive hematoma evacuation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Melbourne: lead

Study Sites (13)

John Hunter Hospital

Newcastle, New South Wales, 2305, Australia

RECRUITING

Prince of Wales Hospital

Sydney, New South Wales, 2031, Australia

NOT YET RECRUITING

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

NOT YET RECRUITING

Westmead Hospital

Sydney, New South Wales, 2145, Australia

NOT YET RECRUITING

Liverpool Hospital

Sydney, New South Wales, 2170, Australia

RECRUITING

The Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

RECRUITING

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

NOT YET RECRUITING

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

RECRUITING

The Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

The Austin Hospital

Melbourne, Victoria, 3084, Australia

NOT YET RECRUITING

Monash Medical Centre

Melbourne, Victoria, 3168, Australia

NOT YET RECRUITING

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Timothy Kleinig

  Royal Adelaide Hospital/University of Adelaide

  PRINCIPAL INVESTIGATOR

• Amal Abou-Hamden

  Royal Adelaide Hospital/University of Adelaide

  PRINCIPAL INVESTIGATOR

• John Laidlaw

  Royal Melbourne Hospital/University of Melbourne

  PRINCIPAL INVESTIGATOR

• J Mocco

  Icahn School of Medicine, Mt Sinai Hospital, New York

  PRINCIPAL INVESTIGATOR

• Christopher Kellner

  Icahn School of Medicine, Mt Sinai Hospital, New York

  PRINCIPAL INVESTIGATOR

• Stephen Davis

  Royal Melbourne Hospital/University of Melbourne

  PRINCIPAL INVESTIGATOR

• Bruce Campbell

  Royal Melbourne Hospital/University of Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melbourne Brain Centre at the Royal Melbourne Hospital

CONTACT

+61 3 9342 4424; info@thembc.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary outcome of Modified Rankin scale (mRS) and secondary outcomes including National Institutes of Health Stroke Scale (NIHSS) are assessed by a blinded clinician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professorial Fellow, Department of Medicine, Royal Melbourne Hospital, Faculty of Medicine, Dentistry and Health Sciences

Model Details: Patients will receive either minimally invasive hematoma evacuation or standard medical therapy

Study Record Dates

• First Submitted: June 13, 2020
• First Posted: June 17, 2020
• Study Start: November 15, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: 2 years after the publication of the primary manuscript
• Access Criteria: Qualified investigators can access data after submission of a project proposal that has been approved by the VISTA-ICH steering committee.

Locations

AU (13)