Cerebral Embolic Load in Patients Undergoing Surgical Aortic Valve Replacement: A Comparison of the Conventional With the Minimized Extracorporeal Circulation Technique Using Transcranial Doppler Ultrasound (AKE-MECC)
Aortic Valve Replacement Using Closed Extracorporeal Circuit. Minimized Versus Conventional Extracorporeal Circulation Technique: Qualitative Differences
研究概览
地位
详细说明
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
Patients undergoing SAVR are included in the study and randomised to either MECC or CECC technique. HITS are continuously bilaterally detected during the entire intraoperative period by transcranial Doppler ultrasound.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Bern、瑞士、3010
- University Hospital Bern
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Conventional Extracorporeal Circulation Technique
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This group of patients receives surgical aortic valve replacement using CECC.
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实验性的：Minimized Extracorporeal Circulation Technique
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This group of patients receives surgical aortic valve replacement using MECC.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Total and interval-related cerebral microembolic load as measured by transcranial Doppler
大体时间：Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)
|
Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
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Cerebral complications, e.g. delirium and stroke as detected clinically
大体时间：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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Redo surgery
大体时间：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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ICU length of stay
大体时间：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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Extubation time
大体时间：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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Thromboembolic complications
大体时间：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital infections
大体时间：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital Mortality
大体时间：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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合作者和调查者
调查人员
- 首席研究员：Thierry Carrel, MD, PhD、Department of Cardiovascular Surgery
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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