NCT01669408Unknown2 期
A Randomized Controlled Trial Evaluating Cold Infusions for Prehospital Induction of Cooling in Awake Stroke Patients (PreCOOL 1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tympanic Temperature
研究概览
简要总结
Elevated body temperature was shown to be associated with worse outcome in acute stroke patients. PreCOOL 1 aims to investigate efficacy, feasibility and safety of prehospital cooling with cold infusions in stroke patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected stroke
- •Symptom onset ≤ 7 days
- •Tympanic temperature ≥ 36.7°C
- •Informed consent by the patient
- •Age ≥ 18 years
排除标准
- •Severe cardiac insufficiency (NYHA ≥ III)
- •New anisocoria, severe nausea, vomiting or headache
- •High-grade heart valve stenosis or insufficiency
- •Acute pulmonary embolism
- •Acute myocardial infarction
- •Threatening ventricular dysrhythmia
- •Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
- •Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
- •Severe renal insufficiency with reduced diuresis
- •Pregnancy
研究组 & 干预措施
Cold infusions
Active Comparator
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
干预措施: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution (Drug)
结局指标
主要结局
Tympanic Temperature
时间窗: from randomization (prehospital) until arrival in the ER, an expected average of 45min
Primary endpoint: Change of tympanic temperature between measurements before prehospital start of cooling an at arrival in the emergency room.
次要结局
- Efficacy(single measurement at arrival in the ER)
- Vital parameters(from randomization (prehospital) until arrival in the ER, an expected average of 45min)
- Tolerability(from randomization (prehospital) until arrival in the ER, an expected average of 45min)
- Safety(from randomization (prehospital) until first neuroimaging (ER), an expected average of 80min)
研究者
Dr. Sven Poli
Dr. Sven Poli, Consultant Neurologist, Principical Investigator
University Hospital Heidelberg
研究点 (1)
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