Evacuation of Lobar Intracranial Hemorrhage Using Microsurgical Technique (ELIMINATE) (ELIMINATE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracerebral Hemorrhage Lobar
• Intervention / Treatment: Procedure: Microsurgical hematoma evacuation

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 Type: Observational
• Enrollment (Estimated): 27

Contacts and Locations

• Study Contact: Name: Michael D HILL, MD; Phone Number: 403-210-7786; Email: michael.hill@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with spontanous lobar ICH who are appropriate for surgical evacuation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single cohort deisgn; Surgical evacuation of ICH using microsurgical technicque.	Procedure: Microsurgical hematoma evacuation; Microsurgical hematoma evacuation using microscope and neuronavigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Quarterly from study onset through study completion with the final recruitment rate recorded at the end of study; total time 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual hematoma volume	Residual hematoma volume	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	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.	at 90 days and 180 days after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forceps forces	Intra-operative forceps forces during microsurgery. These devices have haptic measurement capability and will reocrd the degree of force each time dissection or cautery are used. Recording will be conducted during the entire operative procedure.	Perioperative/peri-procedural

Collaborators and Investigators

• Sponsor: Dr. Michael D Hill
• Collaborators: University of Calgary

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 14, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: intracerebral hemorrhage; lobar ICH
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Cerebral Hemorrhage
• Other Study ID Numbers: ELIMINATE 4.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Within 2 years of publication, the primary data will posted in a public data respository.
• IPD Sharing Time Frame: Within 2 years of study end date.
• IPD Sharing Access Criteria: All researchers after approval by the study steering committee.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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