Phase 1 Study of Mild Induced Hypothermia After Endovascular Revascularization in Acute Ischemic Stroke of the Anterior Circulation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation
研究概览
简要总结
The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years old
- •Symptoms consistent with an ischemic stroke with a large vessel occlusion (MCA, ICA-terminus) as determined by vascular imaging
- •ASPECTS score of 5-7 on non-contrast CT of the brain
- •Ability to undergo endovascular reperfusion therapy
- •Must have no contraindications to general anesthesia
- •A pre-treatment modified Rankin Score of 0 or 1
- •Arterial puncture performed under 8 hours from symptom onset or last seen normal
- •Immediate post reperfusion CT scan shows no hemorrhage
排除标准
- •Bleeding diathesis with a platelet count < 50,000 or INR > 1.5
- •Involved in another clinical trial
- •History of dementia
- •End stage renal disease on hemodialysis
- •History of ventricular dysrhythmias
- •Life threatening medical condition precluding survival under 6 months
- •Presence of an IVC filter
- •Contrast dye allergy with history of anaphylaxis
结局指标
主要结局
Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation
时间窗: 24 Hours
Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying \>30% of the infarct zone with mass effect
次要结局
- Modified Rankin Scale 0-2(90 days post hospitalization)
研究者
Christopher M. Horn, MD
Assistant Professor of Neurology and Neurosurgery
Emory University