Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke; Prospective, Open, Randomized, Multicenter Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- mortality at 3 months
研究概览
简要总结
To study safety and feasibility of mild therapeutic hypothermia after successful recanalization by mechanical endovascular treatment in patients with acute ischemic stroke and proximal arterial occlusion.
详细描述
The current clinical trial is an investigator-initiated one, and it is conducted under the multi-center, randomized, open-label, prospective design. The subjects meeting inclusion/exclusion criteria will be assigned to the treatment group or the control group. The randomization ratio is 1:1. The subjects of the treatment group will receive a 2-day hypothermia therapy followed by the process of recovery of temperature within 30 hours (the recovery phase). After 3 months of the onset of symptoms, mRS scores are measured. This is followed by the closure of the clinical trial.
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
- None
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
- •Subjects who submitted a written informed consent prior to the participation in the current clinical trial (If the subjects have conditions that they cannot decide on study participation according to their own will, they would participate in the study after their legal representatives submitted a written informed consent form. During the period of study participation, if patients' medical conditions are improved, the written informed consent should be submitted again.)
- •Patients with ischemic stroke attributed to carotid artery or middle cerebral artery occlusion achieved successful recanalization (TICI 2b or 3) immediately after endovascular treatment within 8 hours of symptom onset: Onset time was defined as the time when patients were lastly seen normal.
- •Patients of both sexes aged between 18 and 80 years old
- •NIHSS scores of 6-25 points at screening
- •mRS 1 prior to the onset of disease, with proximal cerebral artery occlusion (e.g., those with middle cerebral or internal carotid artery)
排除标准
- •No evaluation for cranial artery before endovascular treatment
- •Patient with emergent stenting insertion in intracranial or extracranial artery
- •Transient ischemic attack or lacunar infarction
- •Platelet counts < 75,000/mm3
- •coagulopathy (INR spontaneously >1.5)
- •Hemodynamic instability
- •acute myocardial infarction, acute unstable angina or severe cardiac failure (NYHA classification ≥III)
- •Pregnant or breastfeeding women
- •Premorbid modified Rankin Scale Scores of > 2 points
- •Hypersensitivity or allergy to following: buspirone, dexmedetomidine, meperidine
- •Intracranial hemorrhage or hemorrhagic transformation in initial CT scan
- •Brain tumor or CNS infection
- •Patients who participated in other clinical trials within 3 months
- •Life expectancy within 1 year
研究组 & 干预措施
Therapeutic hypothermia group
Therapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun)
干预措施: Arctic Sun (Device)
Therapeutic hypothermia group
Therapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun)
干预措施: Saline (Drug)
Control group
Stroke care based on international guidelines
干预措施: Standard treatment (Other)
结局指标
主要结局
mortality at 3 months
时间窗: 3 months after symptom onset
mortality at 3 months
Favorable outcome
时间窗: 3 months after symptom onset
modified Rankin Scale of 0-2 points at 3 months
次要结局
- Improvements in neurological functions(Volume change on diffusion lesion at 5~7 days)
- Symptomatic cerebral hemorrhage(within 5~7 days of symptom onset)
研究者
Moon Ku Han
proffessor
Seoul National University Hospital