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.
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
27
Microsurgical hematoma evacuation using microscope and neuronavigation
Foothills Medical Centre
Calgary, Alberta, Canada
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.
Time frame: Quarterly from study onset through study completion with the final recruitment rate recorded at the end of study; total time 12 months
Residual hematoma volume
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
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
Time frame: 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.
Time frame: at 90 days and 180 days after randomization
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