Intracerebral Hemorrhage LobarELIMINATENCT07697742
Evacuation of Lobar Intracranial Hemorrhage Using Microsurgical Technique (ELIMINATE)
An observational study of Intracerebral Hemorrhage Lobar, run by Dr. Michael D Hill at 1 site in Canada.
Trial summary
ELIMINATE is a cohort study, phase 2A, designed to determine whether a standardized microsurgical procedure to evacuate spontaneous lobar intracranial hemorrhage (ICH) is feasible, safe and surgically efficacious in achieving a postoperative residual ICH volume <15cc on 24-hour postoperative CT imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage Lobar
- What is being tested?
- Microsurgical hematoma evacuation
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adults with spontanous lobar ICH who are appropriate for surgical evacuation.
Who may be able to join
- • Adults > 18 years
- CT evidence of acute, spontaneous lobar ICH defined as located <1cm from the cortical surface
- ICH volume is >30cc but <80cc as measured by (length x width x height)/2
- GCS 5-14 at presentation
- NIHSS >5
- Surgery deemed to be feasible within 16h of symptom onset
Who cannot join
- • Underlying secondary etiology (AVM, tumor, etc. if known or identifiable acutely)
- Intraventricular extension estimated to involve >50% of the lateral ventricle
- Preoperative disability that will affect outcome as measured by modified Rankin Scale score (mRS>1 at baseline)
- Individuals presenting with GCS <5 at presentation
- Primary basal ganglia hemorrhage with lobar extension
- End-stage organ failure or life expectancy <6 months
- For patients in whom the treating clinical team elects to proceed with surgical evacuation as part of clinical care, a standardized evacuation of the hematoma will be performed using neuronavigation for optimal craniotomy planning, microsurgical technique and SmartForceps System for quantifiable intraoperative data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evacuation of Lobar Intracranial Hemorrhage Using Microsurgical Technique (ELIMINATE): A Prospective Observational Surgical Cohort Study of Feasibility, Safety, and Radiographic Outcomes
ELIMINATE is a cohort study, phase 2A, designed to determine whether a standardized microsurgical procedure to evacuate spontaneous lobar intracranial hemorrhage (ICH) is feasible, safe and surgically efficacious in achieving a postoperative residual ICH volume <15cc on 24-hour postoperative CT imaging.
Read the detailed description
The primary objective of ELIMINATE, a prospective, single-centre, observational surgical cohort study, is to determine whether a standardized microsurgical procedure to evacuate spontaneous lobar intracranial hemorrhage (ICH) is feasible, safe and surgically efficacious in achieving a postoperative residual ICH volume <15cc on 24-hour postoperative CT imaging. The secondary objectives include assessment of tool-tissue forces and bleeding, residual ICH volume postoperatively, and determining the recruitment rate for patients with spontaneous lobar ICH.
The primary clinical outcome will be the proportion of enrolled patients achieving residual ICH volume <15cc on postoperative CT scan at 24 hours. Key outcomes are:
Radiographic: percent evacuation; residual volume (continuous + dichotomized). Functional: mRS at 6 months; EQ-5D-5L at 6 months; mortality at 30 and 180 days.
Intraoperative: force metrics; bleeding quantification; operative time; blood loss.
Feasibility: recruitment rate; proportion operated ≤16 hours; completeness of imaging.
Safety: symptomatic rebleeding ≤72h; postoperative deficits; infections; unplanned OR return; 30-day mortality.
A maximum of 27 adult patients will be enrolled.
Inclusion criteria:
- Adults > 18 years
- CT evidence of acute, spontaneous lobar ICH defined as located <1cm from the cortical surface
- ICH volume is >30cc but <80cc as measured by (length x width x height)/2
- GCS 5-14 at presentation
- NIHSS >5
- Surgery deemed to be feasible within 16h of symptom onset
Exclusion criteria:
- Underlying secondary etiology (AVM, tumor, etc. if known or identifiable acutely)
- Intraventricular extension estimated to involve >50% of the lateral ventricle
- Preoperative disability that will affect outcome as measured by modified Rankin Scale score (mRS>1 at baseline)
- Individuals presenting with GCS <5 at presentation
- Primary basal ganglia hemorrhage with lobar extension
- End-stage organ failure or life expectancy <6 months
- For patients in whom the treating clinical team elects to proceed with surgical evacuation as part of clinical care, a standardized evacuation of the hematoma will be performed using neuronavigation for optimal craniotomy planning, microsurgical technique and SmartForceps System for quantifiable intraoperative data.
This study consists of one 180-day study period for each subject. Subjects will be hospitalized for care after their lobar ICH and surgical intervention according to the current standard of care. Subjects will undergo phone assessment on Day 180 by a trained assessor.
- Conditions
- Intracerebral Hemorrhage Lobar
- Being tested
- Microsurgical hematoma evacuation
- Keywords
- intracerebral hemorrhage, lobar ICH
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsurgical hematoma evacuationProcedure or surgery
Microsurgical hematoma evacuation using microscope and neuronavigation
| Study group | Role | What they receive |
|---|---|---|
| Single cohort deisgn | Surgical evacuation of ICH using microsurgical technicque. Receives: Procedure: Microsurgical hematoma evacuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Total recruitment will be recorded each month and report as number of patients recruited per calendar month as an average for duration of the study. The numerator will be the cumulative total number of pateints recruitment and the denominator will be the number of months elapsed since study start. The demoninator can be a fractional number; the numerator will also be a positive integer.
Measured: Quarterly from study onset through study completion with the final recruitment rate recorded at the end of study; total time 12 months
Secondary outcomes (3)
Residual hematoma volume
Residual hematoma volume
Measured: Up to 2 days after enrolment; post-operative core lab assessment of the 18-54 hour follow-up CT brain scan. The Core Lab will measure residual hematoma volume using summative planimetry over the volume of each CT scan slice image.
modified Rankin Scale Score
mRS score is an integer scale ranging from 0 to 6 (7 point interval scale). Lower score are better and the highest score (6) implies death
Measured: at 90 days and 180 days after enrolment.
EuroQoL
EQ5D-5L is a 5 domain scale, with a 5 point Likert scale for the quesiton in each domain. It addresses quality of life and the final score (the EQ5D Index) is adjusted by country to local norms using standardized methodology. Higher index scores inply a higher quality of life.
Measured: at 90 days and 180 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral Hemorrhage LobarStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Michael D Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Sponsor-investigator, Dr. Michael D Hill, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697742
- Sponsor's protocol ID
- ELIMINATE 4.0
- Acronym
- ELIMINATE
- Status last verified
- Jul 2026
- First submitted
- 14 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Within 2 years of publication, the primary data will posted in a public data respository.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evacuation of Lobar Intracranial Hemorrhage Using Microsurgical Technique (ELIMINATE): A Prospective Observational Surgical Cohort Study of Feasibility, Safety, and Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT07697742
- Acronym / sponsor ID
- ELIMINATE / ELIMINATE 4.0
- Conditions
- Intracerebral Hemorrhage Lobar
- Keywords
- intracerebral hemorrhage, lobar ICH
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Dr. Michael D HillUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Jul 2026 (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.
ELIMINATE is a cohort study, phase 2A, designed to determine whether a standardized microsurgical procedure to evacuate spontaneous lobar intracranial hemorrhage (ICH) is feasible, safe and surgically efficacious in achieving a postoperative residual ICH volume <15cc on 24-hour postoperative CT imaging.
Detailed description
The primary objective of ELIMINATE, a prospective, single-centre, observational surgical cohort study, is to determine whether a standardized microsurgical procedure to evacuate spontaneous lobar intracranial hemorrhage (ICH) is feasible, safe and surgically efficacious in achieving a postoperative residual ICH volume <15cc on 24-hour postoperative CT imaging. The secondary objectives include assessment of tool-tissue forces and bleeding, residual ICH volume postoperatively, and determining the recruitment rate for patients with spontaneous lobar ICH.
The primary clinical outcome will be the proportion of enrolled patients achieving residual ICH volume <15cc on postoperative CT scan at 24 hours. Key outcomes are:
Radiographic: percent evacuation; residual volume (continuous + dichotomized). Functional: mRS at 6 months; EQ-5D-5L at 6 months; mortality at 30 and 180 days.
Intraoperative: force metrics; bleeding quantification; operative time; blood loss.
Feasibility: recruitment rate; proportion operated ≤16 hours; completeness of imaging.
Safety: symptomatic rebleeding ≤72h; postoperative deficits; infections; unplanned OR return; 30-day mortality.
A maximum of 27 adult patients will be enrolled.
Inclusion criteria:
- Adults > 18 years
- CT evidence of acute, spontaneous lobar ICH defined as located <1cm from the cortical surface
- ICH volume is >30cc but <80cc as measured by (length x width x height)/2
- GCS 5-14 at presentation
- NIHSS >5
- Surgery deemed to be feasible within 16h of symptom onset
Exclusion criteria:
- Underlying secondary etiology (AVM, tumor, etc. if known or identifiable acutely)
- Intraventricular extension estimated to involve >50% of the lateral ventricle
- Preoperative disability that will affect outcome as measured by modified Rankin Scale score (mRS>1 at baseline)
- Individuals presenting with GCS <5 at presentation
- Primary basal ganglia hemorrhage with lobar extension
- End-stage organ failure or life expectancy <6 months
- For patients in whom the treating clinical team elects to proceed with surgical evacuation as part of clinical care, a standardized evacuation of the hematoma will be performed using neuronavigation for optimal craniotomy planning, microsurgical technique and SmartForceps System for quantifiable intraoperative data.
This study consists of one 180-day study period for each subject. Subjects will be hospitalized for care after their lobar ICH and surgical intervention according to the current standard of care. Subjects will undergo phone assessment on Day 180 by a trained assessor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort deisgn | – | Procedure: Microsurgical hematoma evacuationSurgical evacuation of ICH using microsurgical technicque. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with spontanous lobar ICH who are appropriate for surgical evacuation.
Key inclusion criteria (6 listed)
- • Adults > 18 years
Key exclusion criteria (7 listed)
- • Underlying secondary etiology (AVM, tumor, etc. if known or identifiable acutely)
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 |
|---|---|---|
| Microsurgical hematoma evacuationMicrosurgical hematoma evacuation using microscope and neuronavigation | Procedure or surgery | Single cohort deisgn |
Primary outcome
Recruitment rate
Time frame: Quarterly from study onset through study completion with the final recruitment rate recorded at the end of study; total time 12 months
Total recruitment will be recorded each month and report as number of patients recruited per calendar month as an average for duration of the study. The numerator will be the cumulative total number of pateints recruitment and the denominator will be the number of months elapsed since study start. The demoninator can be a fractional number; the numerator will also be a positive integer.
3 secondary outcomes
Residual hematoma volume
Time frame: Up to 2 days after enrolment; post-operative core lab assessment of the 18-54 hour follow-up CT brain scan. The Core Lab will measure residual hematoma volume using summative planimetry over the volume of each CT scan slice image.
modified Rankin Scale Score
Time frame: at 90 days and 180 days after enrolment.
EuroQoL
Time frame: at 90 days and 180 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. Within 2 years of publication, the primary data will posted in a public data respository.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage Lobar, run by Dr. Michael D Hill at 1 site in Canada.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael D HILL, MD (403-210-7786, michael.hill@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Quarterly from study onset through study completion with the final recruitment rate recorded at the end of study; total time 12 months). 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 13 Jul 2026.