NCT06313710已完成不适用
Head Down Position for Successful Recanalization of Anterior Circulation Large Vessel Occlusion (HOPES3): a Prospective, Randomized, Open Label, Blinded-end Point, Single-center Study
General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年8月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in National Institute of Health stroke scale (NIHSS)
研究概览
简要总结
This is a prospective, randomized, open label, blinded-end point, single-center study, aiming to investigate the effect of head down position in anterior circulation large vessel occlusion patients with successful recanalization after endovascular treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anterior circulation large vessel occlusion who received endovascular treatment within 24 hours of stroke onset;
- •National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment;
- •Successful recanalization (mTICI 2b-3) after endovascular treatment;
- •Cerebral circulation time based on DSA of the stroke side was slower than that of the healthy side after successful recanalization;
- •ASPECTS ≥ 6 on CT or DWI;
- •Absence of parenchymal hematoma on CT images done in the angio suite immediately after the procedure;
- •Modified Rankin Scale score before stroke onset ≤ 1;
- •Signed informed consent by patient or their legally authorized representative.
排除标准
- •Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
- •Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
- •After recanalization, severe and sustained (i.e., > 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication;
- •More than four retrieval attempts in the same vessel;
- •Cardiac insufficiency (NYHA Class ≥II);
- •Pregnancy, plan to get pregnant or during lactation;
- •The estimated life expectancy is less than 6 months due to other serious diseases;
- •Other conditions unsuitable for this clinical study assessed by researcher.
研究组 & 干预措施
control
No Intervention
low dose of head down position
Experimental
-10° Trendelenburg for 30 min
干预措施: head down position (Other)
high dose of head down position
Experimental
-10° Trendelenburg for 60 min
干预措施: head down position (Other)
结局指标
主要结局
Changes in National Institute of Health stroke scale (NIHSS)
时间窗: 24±8 hours
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
次要结局
- ordinal distribution of modified Rankin Score (mRS)(90±7 days)
- percentage of severe adverse events(24±8 hours)
- changes in cerebral edema(24±8 hours)
- Changes in National Institute of Health stroke scale (NIHSS)(10±2 days)
- proportion of excellent functional outcome(90±7 days)
- proportion of favorable functional outcome(90±7 days)
- early neurological improvement (ENI)(24±8 hours)
- changes in infarct volume(24±8 hours)
- all-cause mortality(90±7 days)
- proportion of intraparenchymal hemorrhage (PH)(24±8 hours)
- new stroke or other vascular event(s)(90±7 days)
- proportion of sympomatic intracranial hemorrhage(24±8 hours)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region
研究点 (1)
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