Study on the Safety and Efficacy of Non-Invasive Transcranial Doppler Ultrasound in Promoting Hematoma Clearance for Intracerebral Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Hematoma clearance rate on CT at Day 7±1day after randomization/discharge；
研究概览
简要总结
Intracerebral hemorrhage (ICH) is one of the stroke subtypes with the highest global rates of disability and mortality, accounting for 15%-20% of all strokes. Currently, there is a lack of evidence-based interventions for ICH, with treatment primarily relying on supportive care. There is an urgent clinical need to explore new strategies and technologies. The investigators hypothesize that for ICH patients, best medical treatment combined with a non-invasive ultrasonic scalpel (ultrasound Doppler flow analyzer) may be superior to best medical treatment alone. The primary objective of this study is to determine the safety and efficacy of the non-invasive ultrasonic scalpel in promoting hematoma clearance in ICH patients.
详细描述
This is a multicenter, randomized, double-blind, controlled trial investigating the use of a 2MHz non-invasive ultrasonic scalpel (ultrasound Doppler flow analyzer, registered as Medical System for Ultrasound Diagnosis) in patients with acute ICH. Eligible participants (n=86 will be randomized 1:1 to either the intervention group (ultrasound + standard medical treatment) or the control group (sham ultrasound + standard treatment). The ultrasound intervention involves daily 20-minute sessions for 7 consecutive days. Primary outcomes include hematoma clearance rates and neurological function improvement, assessed via imaging and clinical scales at multiple time points (baseline, 24±12 hours, 72±12 hours, 7±1days/discharge, 3 months). Safety will be monitored through adverse event tracking, vital signs, and neurological examinations. Ethical approval has been obtained, and all participants will provide informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 intracerebral hemorrhage (ICH);
- •Supratentorial ICH;
- •Hematoma volume <30 mL (calculated using the ABC/2 method);
- •Glasgow Coma Scale (GCS) score >9 at randomization;
- •Time from onset to randomization: 48-72 hours;
- •Patient and/or legal representative provides informed consent.
排除标准
- •Intracerebral hemorrhage attributed to other causes (e.g., cerebral aneurysm, cerebrovascular malformation, brain tumor, cerebral venous sinus thrombosis, hemorrhagic transformation of ischemic stroke, head trauma, anticoagulation therapy, hematologic disorders).
- •Hemorrhage located in the infratentorial region.
- •Hemorrhage confined primarily to the ventricular system.
- •Clinical signs or symptoms suggestive of brain herniation (e.g., progressive decline in level of consciousness, diminished or absent pupillary light reflexes, bilateral pyramidal signs).
- •Severe cardiac dysfunction (NYHA Class III or IV).
- •High-risk chronic arrhythmias (e.g., sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia-related syncope without pacemaker implantation).
- •Severe hepatic impairment defined as ALT >2x ULN or AST >2x ULN (ULN = Upper Limit of Normal).
- •Severe renal impairment defined as serum creatinine >1.5x ULN.
- •History of severe asthma or chronic obstructive pulmonary disease (COPD).
- •History of coagulopathy or systemic bleeding disorder.
- •Leukopenia (<2 × 10⁹/L) or thrombocytopenia (<100 × 10⁹/L).
- •Patients scheduled for surgical intervention (including, but not limited to, hematoma evacuation [minimally invasive or conventional], decompressive craniectomy, hematoma aspiration, or external ventricular drainage) prior to the first dose of study treatment.
- •Pre-stroke modified Rankin Scale (mRS) score >
- •Presence of other severe disease resulting in a life expectancy of less than 1 year.
- •Inability to understand the study procedures and/or complete follow-up due to psychiatric illness, cognitive impairment, or emotional disorders.
- •Women who are pregnant or lactating.
- •Participation in another clinical trial within the past 3 months or current participation in another clinical trial.
研究组 & 干预措施
Ultrasound Intervention Group
On the basis of best medical management, 2 MHz non-invasive ultrasonic scalpel was used for intervention within 48-72 hours after the occurrence of intracerebral hemorrhage, 20min/ day, and continued for 7 days.
干预措施: non-invasive ultrasonic scalpel (Device)
Sham Comparator
On the basis of best medical management, a sham non-invasive ultrasonic scalpel (simulating real treatment with zero energy output) was applied within 48-72 hours after the occurrence of intracerebral hemorrhage, 20 min/day for 7 consecutive days
干预措施: Sham Comparator (Device)
结局指标
主要结局
Hematoma clearance rate on CT at Day 7±1day after randomization/discharge；
时间窗: Day 7±1day after randomization/discharge
Hematoma clearance rate is defined as the percentage reduction in intracerebral hematoma volume from baseline to the follow-up CT scan. It is calculated using the formula: \[(Baseline volume - Follow-up volume) / Baseline volume\] x 100%.
次要结局
- Absolute hematoma volume (mL) on CT at 72±12 hours after randomization(72±12 hours after randomization)
- Hematoma expansion on CT at 24±12 hours after randomization(24±12 hours after randomization)
- Neurological improvement at 24±12 hours after randomization (NIHSS(baseline)- NIHSS(24±12 hours))(24±12 hours after randomization)
- Neurological improvement at 72±12 hours after randomization(NIHSS(baseline)- NIHSS(72±12 hours))(72±12 hours after randomization)
- Absolute hematoma volume (mL) on CT at Day 7±1day after randomization/discharge(Day 7±1 day after randomization or discharge)
- Absolute perihematomal edema (PHE) volume (mL) on CT at Day 7±1day after randomization/discharge(Day 7±1 day after randomization or discharge)
- Neurological improvement at Day 7±1day after randomization/discharge(NIHSS(baseline)- NIHSS( Day 7±1day))(Day7±1day after randomization or discharge)
- Modified Rankin Scale (mRS) score at 90±7 days after onset(90±7 days after onset)
研究者
Ruijun Ji
Chief Physician/Professor
Beijing Tiantan Hospital