NCT01615172Unknown不适用
Cannulation of the Artery Axiliaris for Extracorporeal Circulation
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Surrogat endpoint: Number of participants with change from baseline in Neurolocial events at 5th postoperative day (POD) and 3 month after operation
研究概览
简要总结
Comparision of two different cannulation techniques on the neurological outcome in cardiac surcical procedures. Study hypothesis: Cannulation of the axilaris artery can reduce neurolocical side effects.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac procedure with ecc Age 40-85 years CABG and/or valve
排除标准
- •Stenosis of a.subclavia
结局指标
主要结局
Surrogat endpoint: Number of participants with change from baseline in Neurolocial events at 5th postoperative day (POD) and 3 month after operation
时间窗: Participants will be followed for the duration of hospital stay (5 POD) and a follow up visit 3 months after discharge
Neurological events were detected by:NIRO (Near-infrared spectroscopy), EEG (Electrencenphalographie), MRI (Magnet resonance imaging) and test battery (Mini mental status test, HAWIE-R)
次要结局
未报告次要终点
研究者
Arndt-H. Kiessling
Cardia vascular research
Johann Wolfgang Goethe University Hospital
研究点 (2)
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