Minimal Invasive Surgical Intracerebral Hemorrhage Removal (HEALME)

Hyperacute mEchAnicaL Endoscopic Minimally Invasive Surgical (MIS) Intracranial Hemorrhage Evacuation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracranial Hemorrhages
• Intervention / Treatment: Device: Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard Aviv, MD; Phone Number: 78571 6137985555; Email: raviv@toh.ca
• Study Contact Backup: Name: Betty Anne Schwarz, PhD; Phone Number: 17522 6137985555; Email: baschwarz@ohri.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mechanical Minimal Invasive Surgical (MIS) management; Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management	Device: 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.
No Intervention: Best Medical Management (MM); Best medical management per standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of enrolment <=8 hours	Number of patients eligible for treatment recruited	Baseline
Number of patients with good functional outcome	Functional outcome assessed via modified Rankin score (mRS). Change from Day 1 to Day 90 will be assessed (0 no symptoms - 5 severe disability)	Day 1 (baseline), Day 30 and Day 90
Quality of life assessment	Quality of life assessed via NIH Stroke Scale 0: No stroke symptoms 1-4: Minor stroke 5-15: Moderate stroke 16-20: Moderate to severe stroke 21-42: Severe stroke Change from Day 1 to Day 90 will be assessed as well	Day 1, Day 5 and Day 90
Rate of mortality	Number of deaths	Day 7
Rate of mortality	Number of deaths	Day 30
Quality of life EQ-5D-5L	EQ-5D-5L stands for European Quality of Life Five Dimension, the 5-level EQ-5D version (EQ-5D-5L), which was introduced by European Quality of Life Scale group in 2009. EQ-5D-5L is used for self-assessment on activities of daily living. The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness analysis	Costs and outcomes will be assessed within 90 days to compare total costs and health outcomes of mechanical minimal Invasive Surgical Management and Best Medical Management.	Day 90
Number of patients identifying deferred consent in ICH as acceptable	Investigators will secondarily explore the applicability, acceptability, and effects of implementing a deferral of consent policy in an emergency stroke trial.	1-2 years

Collaborators and Investigators

• Sponsor: The Ottawa Hospital
• Investigators: Principal Investigator: Richard Aviv, MD, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Intracranial Hemorrhages; Minimally invasive hematoma evacuation; Hyperacute
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Intracranial Hemorrhages
• Other Study ID Numbers: 20210235-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data for primary and secondary outcomes will be made available.
• IPD Sharing Time Frame: The principal investigator will aim to have data available within 2 year of study completion

IPD Sharing Access Criteria

Authors aim to have the study presented at conferences and published in a peer-reviewed journal.

Participants can search this website to obtain study information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No