Evacuation of Lobar Intracranial Hemorrhage Using Microsurgical Technique (ELIMINATE): A Prospective Observational Surgical Cohort Study of Feasibility, Safety, and Radiographic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •• 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.
研究组 & 干预措施
Single cohort deisgn
Surgical evacuation of ICH using microsurgical technicque.
干预措施: Microsurgical hematoma evacuation (Procedure)
结局指标
主要结局
Recruitment rate
时间窗: 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.
次要结局
- 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)
研究者
Dr. Michael D Hill
Professor, Co-principal Investigator
University of Calgary