Evacuation of Lobar Intracranial Hemorrhage Using Microsurgical Technique (ELIMINATE) (ELIMINATE)
8 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
27
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Michael D HILL, MD
- Numéro de téléphone: 403-210-7786
- E-mail: michael.hill@ucalgary.ca
Lieux d'étude
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 2T9
- Foothills Medical Centre
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Adults with spontanous lobar ICH who are appropriate for surgical evacuation.
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Single cohort deisgn
Surgical evacuation of ICH using microsurgical technicque.
|
Microsurgical hematoma evacuation using microscope and neuronavigation
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recruitment rate
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Residual hematoma volume
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Forceps forces
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
31 décembre 2027
Achèvement de l'étude (Estimé)
31 décembre 2028
Dates d'inscription aux études
Première soumission
14 juin 2026
Première soumission répondant aux critères de contrôle qualité
8 juillet 2026
Première publication (Réel)
13 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ELIMINATE 4.0
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Within 2 years of publication, the primary data will posted in a public data respository.
Délai de partage IPD
Within 2 years of study end date.
Critères d'accès au partage IPD
All researchers after approval by the study steering committee.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .