NCT06486480尚未招募早期 1 期
Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage
Jin Hu0 个研究点目标入组 143 人开始时间: 2025年1月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 143
- 主要终点
- 6-month mRS score
研究概览
简要总结
Clarify the therapeutic differences between robot assisted endoscopic clearance and traditional puncture and external drainage, and establish a new minimally invasive surgical diagnosis and treatment strategy for intraventricular hemorrhage
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
- Single (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 range from 18 to 80 years old;
- •The time from onset to first CT confirmation of intraventricular hemorrhage is less than 24 hours;
- •Before enrollment, CT confirmed that the intraventricular hemorrhage score (modified Graeb score) was ≥ 8 points, and the total score of bilateral lateral ventricles was ≥ 5 points;
- •If there is concurrent cerebral hemorrhage but the hematoma volume is less than 30ml;
- •⑤ First CT to surgery time<72 hours;
- •⑥ GCS ≤ 14.
排除标准
- •① Suspected (unless excluded by angiography or CTA/MRA/MRI) or untreated rupture of cerebral aneurysm, Moyamoya disease, intracranial AVM rupture, or tumor;
- •Patients with a GCS score of 3 and/or fixed dilated pupils and/or no spontaneous breathing;
- •Patients with pre-existing neurological disorders that affect neurological function assessment prior to onset;
- •Coagulation dysfunction;
- •Patients who require long-term anticoagulant treatment;
- •⑥ Use dabigatran, apixaban, and/or rivaroxaban (or drugs of the same class) before symptoms appear; ⑦ Platelet count<100 × 109/L, INR>1.4;
- •⑧ Pregnancy (positive serum or urine pregnancy test);
- •⑨ Subtentorial hemorrhage or brainstem hemorrhage;
- •⑩ Patients who have previously participated in other interventional clinical studies and participated in observational, natural history, and/or epidemiological studies that do not involve intervention are eligible;
- •⑪ Subjects who are expected to not survive until the 180th day of visit; No written informed consent was given by the subjects or legal representatives.
结局指标
主要结局
6-month mRS score
时间窗: 180 days
MRS Scores 6 months after onset
次要结局
- 30 day mortality rate(0-30 days)
研究者
Jin Hu
Huashan Hospital, Fudan University
Huashan Hospital
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