Minimal Invasive Surgical Intracerebral Hemorrhage Removal (HEALME)

The Ottawa Hospital

Status: Not yet enrolling

Conditions: Intracranial Hemorrhages

Treatments: Device: Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation

Study type: Interventional

Funder types: Other

Identifiers

NCT05138341

20210235-01H

Details and patient eligibility

About

This is a feasibility study trial to determine whether hyperacute (≤8 hour) mechanical Minimal Invasive Surgical (MIS) management is feasible and secondarily improves outcome in patients with spontaneous supratentorial intracranial hemorrhage (ICH).

Patients meeting the inclusion and exclusion criteria, will be enrolled and randomized to either minimally invasive hematoma evacuation (MIS) or best medical management alone (MM). Subjects will be randomly assigned by a central web-based system in a 3:1 manner to treatment with MIS or MM. Data for each subject will be collected at the time of enrollment and treatment, and at subsequent follow-up visits.

Full description

The proposed study seeks to determine whether hyperacute (≤8 hour) mechanical MIS management is feasible and improves outcome in patients with spontaneous supratentorial intracranial hemorrhage (ICH).

• Screening The subject will be evaluated as any non-traumatic spontaneous intra-parenchymal hemorrhage patient including medical history screened, available clinical/neurological exams (focused exam, NIHSS, GCS, historical mRS), ECG, laboratory work, and imaging information per institutional standard of care. A CTA (or MRA) will be performed, as standard of care.
• Randomization After all inclusion and exclusion criteria are confirmed and written informed consent obtained, randomization will occur. Subjects will be randomized to best MM or MIS.
• Treatment Procedure (if randomized to MIS) Minimally Invasive Surgical evacuation.
• Treatment Procedure (if randomized to MM) There is no intervention for the control group beyond the current standard of care provided at The Ottawa Hospital. Subjects randomized to the MM group will receive best MM for ICH according to Canadian Best Practice Recommendations for ICH care. Outcomes assessments will be in accordance to table 2.
• Post procedure, D1, D2 and D5 or discharging A post-procedural computed tomographic scan will be obtained within 24 hours (± 6 hours) for MIS group. Clinical assessment such as NIHSS, mRS, NCCT head, computed tomographic Angiogram, adverse event assessment will be conducted as SOC for MIS group (Table 2 in protocol).

A CT will be obtained in MM subjects 24 hours (± 6 hours) after randomization. Adverse event assessment will be conducted for MM subjects 4-6 hours after randomization. Neurological and functional exams will be conducted in D1 and D2 after randomization (Table 2 in protocol).

Follow-up visits (D30, D90): (Both MIS and MM groups) Follow-ups will be combined with phone and onsite visit. D30 will be conducted over the phone, and D90 will be onsite visit. The follow-ups will involve clinical assessment such as NIHSS, Glasgow Coma Scale, EuroQol- 5 Dimension (EQ-5D), mRS, Barthel, Glasgow Outcome Scale (GOSE), adverse event assessment, concomitant. medications.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. CT diagnosed acute spontaneous primary supratentorial ICH.
2. Age >18 years
3. Baseline ICH volume 20-80 ml, estimated using the standard "A*B*C/2"calculation on the baseline CT.
4. NIHSS≥6 and Glasgow Coma Scale score 8-12, on initial screening.
5. Premorbid Modified Rankin score (MRS) ≤1
6. Systolic blood pressure140-180 millimeters of mercury (mmHg) with 160mmHg target according to practice guidelines
7. Randomize and first evacuation attempt ≤8 hours onset using the "last seen normal" principle.
8. Consent obtained from patient or their Substitute Decision Maker prior to enrolment.

Exclusion criteria

1. Infratentorial ICH (Brainstem or cerebellum).
2. ICH secondary to known or suspected trauma, aneurysm, vascular malformation, hemorrhagic conversion of ischemic stroke, venous sinus thrombosis, thrombolytic treatment, tumour, or infection; or an in-hospital ICH or ICH because of any in-hospital procedure or illness.
3. Baseline brain imaging shows evidence of acute or subacute ischemic stroke (chronic infarcts are not an exclusion).
4. Platelets <100000, International Normalized ratio (INR)>1.3 or clotting disorder. Coumadin reversal permitted if not required during hospitalization
5. Serious comorbidities including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease or mechanical valve
6. Impaired brainstem function (bilateral fixed dilated pupils, extensor posturing).
7. Patient considered unstable in opinion of investigator.
8. Positive pregnancy test

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Mechanical Minimal Invasive Surgical (MIS) management

Experimental group

Description:

Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management

Treatment:

Device: Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation

Best Medical Management (MM)

No Intervention group

Description:

Best medical management per standard of care