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

8 juli 2026 bijgewerkt door: Dr. Michael D Hill

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

27

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Single cohort deisgn
Surgical evacuation of ICH using microsurgical technicque.
Procedure: Microsurgical hematoma evacuation
Microsurgical hematoma evacuation using microscope and neuronavigation

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recruitment rate
Tijdsspanne: 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.
Quarterly from study onset through study completion with the final recruitment rate recorded at the end of study; total time 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Residual hematoma volume
Tijdsspanne: 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.
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
Tijdsspanne: at 90 days and 180 days after enrolment.
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
Tijdsspanne: at 90 days and 180 days after randomization
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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Forceps forces
Tijdsspanne: Perioperative/peri-procedural
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Dr. Michael D Hill

Medewerkers

University of Calgary

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

14 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2026

Eerst geplaatst (Werkelijk)

13 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

8 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ELIMINATE 4.0

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Within 2 years of publication, the primary data will posted in a public data respository.

IPD-tijdsbestek voor delen

Within 2 years of study end date.

IPD-toegangscriteria voor delen

All researchers after approval by the study steering committee.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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