Minimal Invasive Surgical Intracerebral Hemorrhage Removal

NCT ID: NCT05138341

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed 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.

Conditions

Intracranial Hemorrhages

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mechanical Minimal Invasive Surgical (MIS) management

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

Group Type: EXPERIMENTAL

Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation

Intervention Type: DEVICE

Patients randomized to MIS group will be undergoing an intervention will get Minimal Invasive Surgical treatment.

The market approved Artemis Device (MIS group) will be used. The Artemis Device, Aspiration Pump, and endoscope are used to rinse (irrigate) this area and to gently suction out the rinsing fluid and any blood or clot in brain. The Device is also designed to prevent clogging during the suction of fluid and blood.

Best Medical Management (MM)

Best medical management per standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation

Patients randomized to MIS group will be undergoing an intervention will get Minimal Invasive Surgical treatment.

The market approved Artemis Device (MIS group) will be used. The Artemis Device, Aspiration Pump, and endoscope are used to rinse (irrigate) this area and to gently suction out the rinsing fluid and any blood or clot in brain. The Device is also designed to prevent clogging during the suction of fluid and blood.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Ottawa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Richard Aviv

Head of Medical Imaging

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Aviv, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Central Contacts

Richard Aviv, MD

Role: CONTACT

raviv@toh.ca

6137985555 ext. 78571

Betty Anne Schwarz, PhD

Role: CONTACT

baschwarz@ohri.ca

6137985555 ext. 17522

Other Identifiers

20210235-01H

Identifier Type: -

Identifier Source: org_study_id