Effectiveness and Safety of Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage: A Prospective and Retrospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Functional Outcome by modified Rankin Scale (mRS)
研究概览
简要总结
This observational cohort study evaluates the real-world effectiveness and safety of minimally invasive surgery (MIS) versus standard medical management in adults with spontaneous deep intracerebral hemorrhage. Patients presenting to Tam Anh General Hospital and People's Hospital 115 within 72 hours of hemorrhage onset will be enrolled and followed for 180 days. Clinical, radiological, and treatment-related variables will be collected, with primary outcome measures including survival and functional outcomes during follow-up period.
详细描述
Spontaneous deep intracerebral hemorrhage (ICH) is a severe neurological condition associated with high mortality and significant long-term disability. Outcomes remain unsatisfactory with standard medical management alone, and conventional craniotomy has not consistently demonstrated a functional benefit. Minimally invasive surgery (MIS), including neuronavigation-guided parafascicular techniques, has been introduced to achieve hematoma evacuation while minimizing damage to surrounding brain structures and subcortical white-matter tracts. While increasing evidence supports the use of MIS in lobar ICH, evidence in patients with basal ganglia hemorrhage remains limited. In addition, previous studies have largely focused on surgery performed within the first 24 hours of symptom onset, and the effectiveness of MIS performed in the extended 24-to-72-hour window remains uncertain.
This retrospective and prospective, multicenter, observational cohort study is being conducted at Tam Anh General Hospital and People's Hospital 115. The study consists of both retrospective and prospective cohorts. The retrospective cohort includes patients treated from November 2024 onward, following approval by the Ministry of Health for the robotic-assisted intracerebral hematoma evacuation procedure at Tam Anh General Hospital, Ho Chi Minh City, and continues through the present. The prospective cohort is planned to enroll patients from June 2026 to June 2028. Eligible participants include those presenting with spontaneous basal ganglia ICH within 72 hours of symptom onset.
Management decisions, including the indication for MIS and the timing of surgical intervention, are determined solely by the treating physicians according to routine clinical practice. No treatment allocation or intervention is dictated by this protocol; instead, the study evaluates real-world clinical practices and outcomes.
Data will be recorded using standardized case report forms and electronic case report forms (CRFs/eCRFs). Collected information includes patient demographics, comorbidities, neurological presentation, laboratory results, radiological characteristics, intraoperative details for patients undergoing MIS, intensive care management, hospital course, and follow-up evaluations. All participants will be followed for 180 days after treatment.
The primary outcome measure is functional status at 180 days. Safety outcomes include mortality and treatment-related adverse events. Prespecified multivariable analyses will be conducted to address potential confounding by indication. Subgroup analyses are planned to compare outcomes according to the timing of MIS (0-24 hours versus 24-72 hours) and other clinically relevant factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Hematoma volume between 30 and 80 mL (calculated using the ABC/2 method)
- •Time from symptom onset to enrollment ≤ 72 hours (for patients with an unknown onset time, the last known well time will be used)
- •Glasgow Coma Scale (GCS) score between 5 and 14
- •Pre-stroke modified Rankin Scale (mRS) score of 0 to 1
排除标准
- •Secondary intracerebral hemorrhage due to trauma, brain tumor, arteriovenous malformation, cerebral aneurysm, or hemorrhagic transformation of ischemic stroke
- •Infratentorial hemorrhage involving the brainstem or cerebellum
- •Primary thalamic hemorrhage
- •Intraventricular extension occupying more than 50% of either lateral ventricle
- •NIHSS score < 5
- •Bilaterally fixed and dilated pupils with no light reflexes
- •Decerebrate posturing
- •Platelet count < 75,000/μL
- •IINR > 1.4 after correction
- •Ongoing anticoagulation that cannot be rapidly reversed
- •Indication for long-term anticoagulation within 5 days of symptom onset
- •End-stage renal disease
- •End-stage liver disease
- •Presence of a mechanical heart valve
- •Comorbid condition associated with a life expectancy < 6 months
- •Inability or unwillingness of the participant or legally authorized representative to provide written informed consent
结局指标
主要结局
Functional Outcome by modified Rankin Scale (mRS)
时间窗: 180 days after symptom onset
Proportion of participants with a favorable functional outcome, defined as mRS score of 0 to 3. Unit of Measure: Percentage of participants.
Functional Outcome by Utility-Weighted modified Rankin Scale (UW-mRS)
时间窗: 180 days after symptom onset
Mean UW-mRS score at 180 days after symptom onset. The UW-mRS is a utility-based measure of functional outcome ranging from 0 (death) to 1 (no symptoms). Unit of Measure: Score (range: 0 to 1)
Safety: All-Cause Mortality at 30 days
时间窗: 30 days after symptom onset
All-cause mortality within 30 days after symptom onset. Unit of Measure: Percentage of participants
Safety: Change in Hematoma Volume (Δ volume)
时间窗: Within 24 hours after MIS (MIS group) or within 6-36 hours after the baseline CT scan (standard medical treatment group)
Δ volume calculated as the difference between hematoma volume measured on the follow-up CT scan (performed within 24 hours after minimally invasive surgery (MIS) for MIS group, or within 6-36 hours after baseline CT scan for standard medical treatment group) and that on the baseline CT scan (the first CT scan performed on hospital admission). Hematoma volume will be measured using the ABC/2 method. Unit of Measure: Milliliters (mL)
Safety: Treatment-Related Complications
时间窗: From treatment initiation through 30 days after symptom onset
Occurrence of one or more treatment-related complications, including rebleeding, surgical site infection or meningitis, new-onset seizures, progressive cerebral edema, hydrocephalus requiring external ventricular drainage or shunt placement, hypotension or shock requiring specific treatment, and neurological readmission within 30 days. Unit of Measure: Number of participants with one or more treatment-related complications
次要结局
- Functional Outcome According to Timing of Minimally Invasive Surgery (MIS)(180 days after symptom onset)
- Safety: All-Cause Mortality According to Timing of Minimally Invasive Surgery (MIS)(30 days after symptom onset)
- Safety: Treatment-Related Complications According to Timing of Minimally Invasive Surgery (MIS)(From treatment initiation through 30 days after symptom onset)