Efficacy and Safety of Endovascular Thrombectomy With Versus Without Hypothermia in Acute Large Vessel Occlusion Stroke: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Modified Rankin scale score (mRS)
研究概览
简要总结
Reducing or suspending the increase of the infarcted core, i.e., "freezing" the ischemic penumbra, may help improve the efficacy of mechanical thrombectomy. Hypothermia effectively reduces the metabolic level of brain tissue, may prolong the time window for recanalization therapy, and its multi-target therapeutic effect make it one of the most promising neuro-protection approach.
In recent years, hypothermia has been increasingly used to treat acute ischemic stroke. However, its role in acute ischemic stroke is unclear.
The objective of this trial is to investigate whether hypothermia combined with endovascular thrombectomy could add additional benefit without increasing the risk of adverse events such as pneumonia, intracerebral hemorrhage, and mortality.
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
- •Aged ≥ 18 years or more;
- •acute ischemic stroke within 24 hours from onset to randomization;
- •NIHSS ≥6 points before randomization;
- •Internal carotid artery, or the middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA/DSA;
- •Baseline ASPECTS score ≥ 3 and ≤8, or cerebral infarction core volume < 100ml;
- •The patient decides to undergo endovascular therapy;
- •The patient or patient's representative signs a written informed consent form.
排除标准
- •CT or MR evidence of hemorrhage;
- •Currently pregnant or lactating (women patients);
- •Allergy to radiographic contrast agents, or nitinol devices;
- •Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
- •Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
- •Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
- •Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
- •Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;
- •Intracranial aneurysm, arteriovenous malformation;
- •Any terminal illness with life expectancy less than 6 months;
- •Participating in other clinical trials.
结局指标
主要结局
Modified Rankin scale score (mRS)
时间窗: 90 days post-randomization
Modified Rankin scale score (mRS): scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
次要结局
- Early neurological improvement(72 hours post-randomization)
- EQ-5D-5L scale score(90 days post-randomization)
- Incidence of symptomatic intracranial hemorrhage (SICH)(48 hours post-randomization)
- incidence of any intracranial hemorrhage (any ICH)(48 hours post-randomization)
- Difference of hematocrit between baseline and 24-hour post-randomization(24-hour post-randomization)
- Complications related to operation and device(90 days post-randomization)
- Successful reperfusion at final angiogram(At the end of angiography or procedure)
- Excellent outcome(90 days post-randomization)
- Functional independence(90 days post-randomization)
- Moderate outcome(90 days post-randomization)
- Difference between baseline and within 48h after procedure of infarction core volume (ml)(48 hours post-randomization)
- Reperfusion on follow-up CT or MR angiography(48 hours post-randomization)
- 90-day mortality(90 days post-randomization)
- Other serious adverse events(90 days post-randomization)
- Non-hemorrhagic serious adverse event rate(90 days post-randomization)
研究者
Zhongming Qiu
Professor
Xinqiao Hospital of Chongqing