Aortic Valve Replacement Using Closed Extracorporeal Circuit. Minimized Versus Conventional Extracorporeal Circulation Technique: Qualitative Differences
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Total and interval-related cerebral microembolic load as measured by transcranial Doppler
研究概览
简要总结
In this study, the investigators aim to compare cerebral embolic load in patients undergoing surgical aortic valve replacement using either the minimized extracorporeal circulation or the conventional extracorporeal circulation technique. The detection of cerebral emboli is performed not-invasively by transcranial Doppler detection of high-intensity transient signals representing solid or gaseous microembolism in the middle cerebral arteries. The investigators hope to get more insight in the mechanism (incl. quantity) of cerebral embolism during aortic valve surgery using extracorporeal circulation.
详细描述
Background
The gold standard to treat severe aortic valve stenosis is currently the surgical aortic valve replacement (SAVR) using conventional extracorporeal circulation (CECC). SAVR, however, can be performed also on minimized extracorporeal circulation (MECC), which is characterized by reduced priming volume and interfaces between blood and artificial surfaces and blood-air interface, respectively. Further technical developments of the MECC system together with reports on less induction of the coagulation cascade and activation of inflammatory systemic response may account for a reduced incidence of microbubble generation with MECC system.
Objective
The aim of the is to investigate the procedural-related incidence of high-intensity transient signals (HITS) representing solid or gaseous microembolism reaching the cerebral vessels.
Methods
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
- •Isolated Severe Aortic Valve Stenosis
- •No other cardiac disease
- •No other coronary heart disease
- •Written informed consent
- •Exclusion Criteria
- •Double valve surgery
- •Concomitant coronary artery bypass surgery
- •Vascular surgery
- •Age < 18 yrs.
- •Age > 80 yrs.
排除标准
- 未提供
结局指标
主要结局
Total and interval-related cerebral microembolic load as measured by transcranial Doppler
时间窗: Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)
次要结局
- Cerebral complications, e.g. delirium and stroke as detected clinically(In-hospital period (until hospital discharge, duration approx. 7-10 days))
- Redo surgery(In-hospital period (until hospital discharge, duration approx. 7-10 days))
- In-hospital Mortality(In-hospital period (until hospital discharge, duration approx. 7-10 days))
- Extubation time(In-hospital period (until hospital discharge, duration approx. 7-10 days))
- In-hospital infections(In-hospital period (until hospital discharge, duration approx. 7-10 days))
- ICU length of stay(In-hospital period (until hospital discharge, duration approx. 7-10 days))
- Thromboembolic complications(In-hospital period (until hospital discharge, duration approx. 7-10 days))