Haemo-autologous Antegrade Repriming (HAR) Clinical Trial for Validation as Minimum Impact Perfusion Strategy in Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
Haemo-autologous Antegrade Repriming (HAR) is a procedure based in the combination of evidence proven measures designed to reduce the haemodilution caused by establishing the cardiopulmonary bypass (CPB) during cardiac surgery.
This clinical trial aims to determinate, in one hand, the benefits related to HAR in terms of transfusion, ICU stay, ventilation time, early mortality and complications. In the other hand analyzes the gaseous microemboli (GME) load, comparing the oxygenators venting technology´s efficiency in treatment and control group, and its relation with patient´s neurocognitive status.
详细描述
HAR is a repriming technique based in Retrograde Autologous Priming (RAP), that has been implemented by recently recommended measures in terms of reducing blood transfusions.
The expected clinical benefits are related to hemodilution´s reduction up to only 300ml. The extracorporeal circuit has been reduced to 3/8 inch diameter in both lines, reducing the surface up to 1000ml of dynamic priming.
Vacuum assisted venous drainage (VAVD) allows to empty the venous line after priming and deairing, facilitating the venous flow for CPB initiation.
The antegrade repriming eliminates the maximum amount of crystalloid contained in the circuit, displacing it to a collector bag, by using autologous blood sequestered from the arterial line to the hardshell reservoir.
HAR reduces the CPB hemodilution related to priming from 1500 to 300 ml preventing the usual sudden haemoglobin level reduction occured during every extracorporeal techinque´s establishment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patient and neurocognitive examinator does not know the arm assigned, as well as the anaesthesiologist, surgeon and ICU team. Only the perfusionist has access to de randomization sheet before choosing and set up of the extracorporeal circuit.
In order to guarantee the blinding, the perfusionist must be hidden during the possible HAR performance, using a field blanket to isolate the oxygenator´s area. Anestesiologist´s proceed in every case as if HAR is assigned maintaining a mean arterial pressure over 60 mmHg.
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients purposed to undergo elective cardiopulmonary bypass for cardiac valve surgery or other pathologies requiring to open heart chambers.
排除标准
- •Urgency and emergency
- •Heart transplantations
- •Severe cognitive affection
- •Active sepsis
- •Previous anemia
- •Early re-intervention
- •Pre-Op extracorporeal membrane oxygenation (ECMO) support
- •Hemodynamic unstability during HAR
- •Any clinical condition that may force protocol deviation
结局指标
主要结局
Mortality
时间窗: 1 year
Incidence of death during hospital stay
Transfusion
时间窗: 1 year
Blood product consumption during patients hospital stay
ICU stay
时间窗: 1 year
Length of stay at Intensive Care Unit. (days)
Ventilation time
时间窗: 1 year
Hours under mechanical ventilation after surgery
Complications
时间窗: 1 year
Incidence of neurological, respiratory, urinary, cardiologic complications and multiorganic failure
次要结局
- Emboli number(1 year)
- Emboli Volume(1 year)
- Emotional regulation(6 months after surgery)
- Visual work memory variation and emboli(6 months after surgery)
- Executive functions and emboli(6 months after surgery)
- Visual memory and cognitive status evaluation and emboli(6 months after surgery)
研究者
Juan Blanco Morillo
Principal Investigator
Hospital Universitario Virgen de la Arrixaca