Head Positioning After Endovascular Therapy for Acute Ischemic Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,368
- 试验地点
- 134
- 主要终点
- Modified Rankin scale score (mRS)
研究概览
简要总结
The aim of this trial is to investigate whether head elevation position after endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.
详细描述
The optimal head position for patients with acute ischemic stroke (AIS) remains uncertain. The HeadPoS study revealed that there is no significant difference in disability outcomes between patients who are placed in a lying-flat position for 24 hours and those who are placed in a sitting-up position with the head elevated to at least 30 degrees for 24 hours. However, this study included both patients with ischemic and hemorrhagic strokes, and most of the patients had mild strokes (median National Institutes of Health Stroke Scale score of 4). It is unclear how to arrange the patient's head position after endovascular treatment.
The hypothesis of this trial: Compared with the lying flat head positioni, the head elevation position after endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Clinical signs consistent with acute ischemic stroke;
- •Age ≥ 18 years old;
- •Proved anterior circulation large vessel occlusion on digital subtraction angiography (ICA, M1, M2) with/without cervical lesion (tandem);
- •NIHSS score ≥ 8 points before endovascular treatment;
- •ASPECTS score ≤ 7 points before endovascular treatment;
- •Successful vessel recanalization after endovascular treatment (defined as an eTICI score of 2b, 2c, or 3) ；
- •The time from onset to randomization ≤ 24 hours (the onset time is defined as the last normal time);
- •Written informed consent is obtained from patients and/or their legal representatives.
排除标准
- •Pre-stroke mRS score>1 point;
- •Patients with acute occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation);
- •Currently in pregnant or lactating or serum beta HCG test is positive on admission;
- •Contraindications to a flat head position;
- •Any terminal illness with life expectancy less than 6 months;
- •Participating in other clinical trials;
- •Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
- •Unlikely to be available for 90-day follow-up.
结局指标
主要结局
Modified Rankin scale score (mRS)
时间窗: 90 days
disability level. The presence of impairments determines the transitions from mRS score 0 to mRS score 1 (symptoms) and mRS score 5 to mRS score 6 (death).
次要结局
- Health-related quality of life, assessed with the EuroQol-visual analogue scales (EQ-VAS)(90 days)
- Symptomatic intracerebral hemorrhage incidence (Heidelberg Criteria)(within 72 hours after randomized)
- Mortality within 90 days(90 days)
- Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1)(90 days)
- Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)(90 days)
- severe adverse events(within 90 days)
- Incidence of pulmonary infections(within 72 hours after randomized)
- Proportion of patients functionally independent (mRS score 0 to 2) at 90 days(Within 90 days90 days)
- Brain edema(within 72 hours after randomized)
- Any type of intracerebral hemorrhage (Heidelberg Criteria)(within 72 hours after randomized)
- Malignant Brain Edema(within 72 hours after randomized)
- Improvement in National Institute of Health stroke scale (NIHSS) score between baseline and 5~7d(at 5~7 days after randomization)
研究者
Zhengzhou Yuan
MD
The Affiliated Hospital Of Southwest Medical University