Evaluation Of The Efficacy And Safety Of Minimally Invasive Surgery In Patients With Spontaneous Deep Intracerebral Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure 1 - Efficacy: Functional Outcome by Modified Rankin Scale (mRS)
研究概览
简要总结
This observational cohort study evaluates the safety and effectiveness of minimally invasive surgery (MIS) compared with standard medical management in adults with spontaneous deep intracerebral hemorrhage. Consecutive patients admitted to People's Hospital 115 and Tam Anh General Hospital will be enrolled within 72 hours of onset. Clinical and imaging data will be collected prospectively, and outcomes including survival and functional status will be assessed through 180 days.
详细描述
Spontaneous deep intracerebral hemorrhage (ICH) is associated with high early mortality and long-term disability. Conventional craniotomy has not consistently improved functional outcomes, while medical management alone often results in poor prognosis. Minimally invasive surgery (MIS), including parafascicular approaches guided by neuronavigation, is designed to evacuate hematomas with reduced disruption of critical white-matter tracts. Evidence supporting MIS is more robust in lobar ICH, whereas data for basal ganglia hemorrhage remain limited. Furthermore, most prior studies restricted surgical intervention to within 24 hours from onset, leaving uncertainty regarding potential benefit when performed between 24 and 72 hours.
This prospective, multicenter, observational cohort study is conducted at People's Hospital 115 and Tam Anh General Hospital. Consecutive patients admitted with spontaneous basal ganglia ICH are enrolled within 72 hours of onset. Decisions regarding MIS, including whether to operate and the timing of surgery, are made by treating clinical teams in routine practice. The study does not assign interventions but documents real-world management and outcomes.
Data are captured prospectively using standardized CRFs and electronic CRFs. Information includes demographics, comorbidities, presenting neurological status, laboratory and imaging findings, details of MIS when performed, intensive care and hospital course, and follow-up assessments through 180 days. The primary endpoint is functional outcome at 180 days, while safety endpoints include mortality and treatment-related complications. Analyses are planned using prespecified multivariable approaches to account for confounding by indication. Additional subgroup analyses will assess outcomes by timing of MIS (0-24 vs 24-72 hours) and other clinically relevant variables.
By focusing on basal ganglia hemorrhage in contemporary Vietnamese stroke centers, this study is intended to generate real-world evidence on the effectiveness and safety of MIS in deep ICH and inform selection criteria and timing for future interventional trials.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •Spontaneous basal ganglia intracerebral hemorrhage confirmed by non-contrast CT scan
- •Hematoma volume 30-80 mL (ABC/2 method)
- •Time from onset/last known well ≤ 72 hours
- •Glasgow Coma Scale (GCS) score 5-14 at admission
- •Pre-stroke modified Rankin Scale (mRS) score 0-1
排除标准
- •Secondary intracerebral hemorrhage due to trauma, tumor, vascular malformation, aneurysm, or hemorrhagic transformation of ischemic stroke
- •Infratentorial hemorrhage (brainstem or cerebellum)
- •Primary thalamic hemorrhage
- •Extensive intraventricular hemorrhage (>50% of one lateral ventricle)
- •NIHSS < 5 at admission
- •Bilateral fixed dilated pupils without light reflex
- •Decerebrate posture
- •Platelet count < 75,000/µL
- •INR > 1.4 after correction
- •Ongoing anticoagulation that cannot be rapidly reversed
- •Indication for long-term anticoagulation within 5 days of onset
- •End-stage renal disease
- •End-stage liver disease
- •Presence of mechanical heart valve
- •Any comorbidity with life expectancy < 6 months
- •Patient or legal representative unwilling or unable to provide written informed consent
结局指标
主要结局
Primary Outcome Measure 1 - Efficacy: Functional Outcome by Modified Rankin Scale (mRS)
时间窗: 180 days after intracerebral hemorrhage
Proportion of participants achieving favorable functional outcome defined as mRS 0-3. Unit of Measure: Percentage of participants
Primary Outcome Measure 2 - Efficacy: Functional Outcome by Utility-Weighted mRS (UW-mRS)
时间窗: 180 days after intracerebral hemorrhage
Mean UW-mRS score at 180 days after intracerebral hemorrhage. The UW-mRS is a continuous, utility-weighted measure of functional outcome ranging from 0 (death) to 1 (no symptoms). Unit of Measure: Score (0-1 scale)
Primary Outcome Measure 4 - Safety: Procedure-Related Complications
时间窗: Within hospitalization and up to 30 days after intracerebral hemorrhage
Incidence of major complications related to minimally invasive surgery or medical management, including but not limited to rebleeding, infection, seizures, or other serious adverse events as judged by the investigators. Unit of Measure: Number of participants with complications
Primary Outcome Measure 3 - Safety: All-Cause Mortality
时间窗: 30 days after intracerebral hemorrhage
Number of participants who die from any cause within 30 days after intracerebral hemorrhage. Unit of Measure: Percentage of participants
次要结局
- Secondary Outcome Measure 1: Functional Outcome by Timing of MIS (0-24 Hours vs 24-72 Hours)(180 days after intracerebral hemorrhage)
- Secondary Outcome Measure 2: All-Cause Mortality at 30 Days by Timing of MIS (0-24 Hours vs 24-72 Hours)(30 days after intracerebral hemorrhage)
- Secondary Outcome Measure 3: Procedure-Related Complications by Timing of MIS (0-24 Hours vs 24-72 Hours)(Within hospitalization and up to 30 days after intracerebral hemorrhage)
研究者
Huynh Quoc Huy
Principal Investigator, Department of Neurology, People's Hospital 115
115 People's Hospital