NCT01894724已完成1 期
Targeted Cerebral Hypothermia During Cardiac Surgery: A Feasibility Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Freedom from major adverse events related to the use of the NeuroSave device
研究概览
简要总结
This study designed to evaluate the safety and feasibility of the NeuroSave device to rapidly reduce brain temperature while maintaining the brain at a lower temperature than the body core during cardiac surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Undergoing coronary revascularization or valvular cardiac surgery
- •The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Human Research Ethics Committee (HREC) of the respective clinical site
- •The study patient agrees to comply with all study -related procedures
排除标准
- •Women known or suspected to be pregnant (as confirmed by a pregnancy test for all women of child-bearing age)
- •Past history of cerebrovascular accident (stroke or TIA)
- •History of clinically diagnosed active psychiatric conditions
- •Emergency or salvage cardiac valve operations
- •Body weight < 50 kg
- •Leukopaenia (WBC < 3000 cell/mL), anaemia (Hgb < 11g/dL), Thrombocytopaenia (Plt < 50,000 cell/mL)
- •Active upper GI bleeding within 3 months (90 days) prior to procedure
- •Renal insufficiency (creatinine > 265 micromol/L) and/or renal replacement therapy at the time of screening
- •Estimated life expectancy < 12 months (365 days)
- •Structural abnormality or disease of nose, mouth, pharynx and oesophagus (excluding gastric reflux oesophagus disease),
- •Currently participating in an investigational drug or another device study that would potentially impact the results of this study as determined by the PI. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials
结局指标
主要结局
Freedom from major adverse events related to the use of the NeuroSave device
时间窗: Surgery through discharge (up to 5 days post-surgery)
次要结局
- Brain-core temperature differential during cardiac surgery(Continuously assessed over course of cardiac surgery)
研究者
研究点 (2)
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