Intracranial HemorrhagesHEALMENCT05138341
Minimal Invasive Surgical Intracerebral Hemorrhage Removal
A study testing Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation in people with Intracranial Hemorrhages, run by The Ottawa Hospital.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hemorrhages
- What is being tested?
- Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Baseline brain imaging shows evidence of acute or subacute ischemic stroke (chronic infarcts are not an exclusion).
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation
- Keywords
- Intracranial Hemorrhages, Minimally invasive hematoma evacuation, Hyperacute
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive surgical (MIS) intracranial hemorrhage EvacuationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Minimal Invasive Surgical (MIS) management | Experimental | Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management Receives: Device: Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation |
| Best Medical Management (MM) | No intervention | Best medical management per standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of enrolment <=8 hours
Number of patients eligible for treatment recruited
Measured: 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)
Measured: 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
Measured: Day 1, Day 5 and Day 90
Rate of mortality
Number of deaths
Measured: Day 7
Rate of mortality
Number of deaths
Measured: 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
Measured: Day 90
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Nov 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HemorrhagesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ottawa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Richard Aviv, The Ottawa Hospital
- Investigators
- Richard Aviv, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138341
- Sponsor's protocol ID
- 20210235-01H
- Acronym
- HEALME
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2021
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data for primary and secondary outcomes will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperacute mEchAnicaL Endoscopic Minimally Invasive Surgical (MIS) Intracranial Hemorrhage Evacuation
- ClinicalTrials.gov ID
- NCT05138341
- Acronym / sponsor ID
- HEALME / 20210235-01H
- Conditions
- Intracranial Hemorrhages
- Keywords
- Intracranial Hemorrhages, Minimally invasive hematoma evacuation, Hyperacute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- The Ottawa HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Mechanical Minimal Invasive Surgical (MIS) management | Experimental | Device: Minimally invasive surgical (MIS) intracranial hemorrhage EvacuationMinimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management |
| Best Medical Management (MM) | No intervention | –Best medical management per standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
- Baseline brain imaging shows evidence of acute or subacute ischemic stroke (chronic infarcts are not an exclusion).
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive surgical (MIS) intracranial hemorrhage EvacuationPatients 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. | Device | Mechanical Minimal Invasive Surgical (MIS) management |
Primary outcome
Feasibility of enrolment <=8 hours
Time frame: Baseline
Number of patients eligible for treatment recruited
Number of patients with good functional outcome
Time frame: Day 1 (baseline), Day 30 and Day 90
Functional outcome assessed via modified Rankin score (mRS). Change from Day 1 to Day 90 will be assessed (0 no symptoms - 5 severe disability)
Quality of life assessment
Time frame: Day 1, Day 5 and Day 90
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
Rate of mortality
Time frame: Day 7
Number of deaths
Rate of mortality
Time frame: Day 30
Number of deaths
Quality of life EQ-5D-5L
Time frame: Day 90
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
2 secondary outcomes
Cost-effectiveness analysis
Time frame: Day 90
Number of patients identifying deferred consent in ICH as acceptable
Time frame: 1-2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: Yes. De-identified data for primary and secondary outcomes will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Aviv, MD principal investigator
Ottawa Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation in people with Intracranial Hemorrhages, run by The Ottawa Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Aviv, MD (6137985555 ext. 78571, raviv@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of enrolment <=8 hours (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.