Minimal Invasive Surgical Intracerebral Hemorrhage Removal

NCT05138341 | Unknown DMC

• 1 other identifier: 20210235-01H
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intracranial Hemorrhages

Keywords

Intracranial Hemorrhages; Minimally invasive hematoma evacuation; Hyperacute

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Cost-effectiveness analysis

  Day 90

• Number of patients identifying deferred consent in ICH as acceptable

  1-2 years

Study Arms (2)

Mechanical Minimal Invasive Surgical (MIS) management

EXPERIMENTAL

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

Device: Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation

Best Medical Management (MM)

NO INTERVENTION

Best medical management per standard of care

Interventions

Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation 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.

Mechanical Minimal Invasive Surgical (MIS) management

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Infratentorial ICH (Brainstem or cerebellum).
• 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.
• Platelets \<100000, International Normalized ratio (INR)\>1.3 or clotting disorder. Coumadin reversal permitted if not required during hospitalization
• Serious comorbidities including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease or mechanical valve
• Impaired brainstem function (bilateral fixed dilated pupils, extensor posturing).
• Patient considered unstable in opinion of investigator.
• Positive pregnancy test

Sponsors & Collaborators

• The Ottawa Hospital: lead

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

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

• Richard Aviv, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Aviv, MD

CONTACT

6137985555; raviv@toh.ca

Betty Anne Schwarz, PhD

CONTACT

6137985555; baschwarz@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: D90 evaluations of mRS, NIHSS, Barthel Index will be performed by an evaluator blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical Imaging

Model Details: Subjects will be randomized to either minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management (MIS group) or best medical management alone (3:1) (MM)

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 30, 2021
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: The principal investigator will aim to have data available within 2 year of study completion
• 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.