Minimal Invasive Surgical Intracerebral Hemorrhage Removal

Intracranial Hemorrhages Clinical Trial

— HEALME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05138341
• Other study ID #: 20210235-01H
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: The Ottawa Hospital
• Contact: Richard Aviv, MD
• Phone: 6137985555
• Email: raviv[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhages

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Ottawa Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of enrolment <=8 hours	Number of patients eligible for treatment recruited	Baseline
Primary	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
Primary	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
Primary	Rate of mortality	Number of deaths	Day 7
Primary	Rate of mortality	Number of deaths	Day 30
Primary	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	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
Secondary	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