Head dOwn Position Before Endovascular Treatment for Large veSsel Occlusion (HOPES5): a Prospective, Randomized, Open Label, Blinded-end Point, Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- early neurologic improvement (ENI)
研究概览
简要总结
Recent studies suggest that head-down positioning (HDP) intervention may improve outcomes in ischemic stroke. In the era of reperfusion therapy, a key protective strategy is to administer neuroprotective interventions before recanalization to reduce the loss of the ischemic penumbra, thereby salvaging more penumbral tissue after revascularization and ultimately improving clinical outcomes. Based on this concept, and considering the neuroprotective effects of HDP, the investigators hypothesize that HDP intervention prior to endovascular therapy (EVT) in patients with large vessel occlusion could improve clinical outcomes. This hypothesis is further supported by a recent clinical study (NCT03728738), which demonstrated that compared to a sitting up position (30°), a flat supine position (0°) before EVT significantly reduced the incidence of neurological deterioration prior to the procedure. Building on the above rationale, this trial aims to investigate the efficacy and safety of HDP intervention prior to EVT in patients with large vessel occlusion.
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
- •Age ≥ 18 years;
- •Patients with acute large vessel occlusion scheduled for endovascular thrombectomy within 24 hours of symptom onset;
- •Baseline National Institute of Health Stroke Scale (NIHSS) ≥ 6;
- •Expected waiting time from randomization to femoral artery puncture is more than 30 minutes;
- •ASPECTS/pc-ASPECTS score ≥ 6 on baseline non-contrast CT or DWI;
- •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;
- •Severe hypertension before randomization (systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg);
- •Cardiac insufficiency (NYHA Class ≥II);
- •Pregnancy, plan to get pregnant or during lactation;
- •Patients at significant risk of aspiration (e.g., obvious nausea and vomiting);
- •The estimated life expectancy is less than 6 months due to other serious diseases;
- •Other conditions unsuitable for this clinical study assessed by researcher.
结局指标
主要结局
early neurologic improvement (ENI)
时间窗: 24±8 hours
ENI was defined as more than 4-point decrease in NIHSS within 24±8 hours;
次要结局
- proportion of intraparenchymal hemorrhage (PH)(24±8 hours)
- all-cause mortality(10±2 days)
- proportion of symptomatic intracranial hemorrhage(24±8 hours)
- proportion of good collateral circulation status(during the first angiography examination)
- Change in National Institutes of Health Stroke Scale (NIHSS)(10±2 days)
- Changes in cerebral infarct volume(24±8 hours)
- Changes in cerebral edema(24±8 hours)
- proportion of modified Rankin Scale (mRS) 0-1(90±7 days)
- proportion of modified Rankin Scale (mRS) 0-2(90±7 days)
- ordinal distribution of modified Rankin Scale (mRS)(90±7 days)
- new stroke or other vascular event(s)(90±7 days)
- percentage of severe adverse events(24±8 hours)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region