Evacuation of Lobar Intracranial Hemorrhage Using Microsurgical Technique (ELIMINATE)

NCT07697742 | Not Yet Recruiting DMC

• 1 other identifier: ELIMINATE 4.0
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracerebral Hemorrhage Lobar

Keywords

intracerebral hemorrhage; lobar ICH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  at 90 days and 180 days after enrolment.

• EuroQoL

  at 90 days and 180 days after randomization

Other Outcomes (1)

• Forceps forces

  Perioperative/peri-procedural

Study Arms (1)

Single cohort deisgn

Surgical evacuation of ICH using microsurgical technicque.

Procedure: Microsurgical hematoma evacuation

Interventions

Microsurgical hematoma evacuation PROCEDURE

Microsurgical hematoma evacuation using microscope and neuronavigation

Single cohort deisgn

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Michael D Hill: lead
• University of Calgary: collaborator

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michael D HILL, MD

CONTACT

403-210-7786; michael.hill@ucalgary.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Co-principal Investigator

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 2 years of study end date.
• Access Criteria: All researchers after approval by the study steering committee.

Locations

CA (1)