A Multi-Center, Open Label, Single Group, Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 6
- 主要终点
- Major Deviation in Cardioplexol application
研究概览
简要总结
This is a multi-center, open label, single group, observational study designed to evaluate the effects of a Cardioplexol™ preparation and administration training program proposed to cardiac surgeons and cardiotechnicians inexperienced in the use of Cardioplexol™.
The training program aims at increasing the efficacy of Cardioplexol administration while reducing the risk of false manipulations. During the training possible risks and consequences of incorrect applications as well as the measures to take in case of administration error, are discussed. The training program includes one standardized theoretical part and one practical part consisting of a direct intra-operative coaching of surgeons practicing their first 2 operations.
The effect of the training will then be assessed by evaluating each trained surgeon's 4 next consecutive patients operated with Cardioplexol and without the coach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Male or female patients between 18 and 80 years of age;
- •The patient's pre-operative evaluation indicates the need for a primary elective cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve repair/replacement;
- •The operation can be carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine;
- •Patients who provide signed written informed consent.
排除标准
- •Pre-operative EF of less than 30%;
- •Pre-operative IABP;
- •Pre-operative catecholamine support;
- •History of myocardial infarction within less than 7 days;
- •Previous history of cardiac surgery, including the implantation of a pace maker or an ICD;
- •Active myocarditis and/or endocarditis;
- •Aortic valve insufficiency severity grade more than 1;
- •Under dialysis;
- •Pre-operative serum creatinine value of more than 2.0 mg/dl;
- •Known hematologic disorder;
- •Treatment with anti-vitamin K;
- •History of HIT;
- •Participating in a concomitant research study of an investigational product;
- •Pregnant or lactating;
- •Intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
研究组 & 干预措施
Cardioplexol™- Cardioplegia Solution
Cardioplexol™ will be used as cardioplegic solution in cardiac surgery
干预措施: Cardioplegia Solution (Drug)
结局指标
主要结局
Major Deviation in Cardioplexol application
时间窗: During surgery
Number of major deviations from the application of Cardioplexol™ as determined by the pre-specified training documentation (incorrect volume of initial dose, incorrect volume of second/third/fourth dose, incorrect duration of injection of initial dose, incorrect timing of application of initial dose, incorrect timing of application of second/third/fourth dose).
次要结局
- TnT Values(During the first 24 hours following myocardial reperfusion)
- Complete Cardiac Arrest(During Surgery)
- Catecholamine(During during aortic cross-clamping and during the first 24 hours)
- ICU stay(During follow-up phase after surgery up to 35 days)
- Mortality(During the first 24 hours following coronary reperfusion)
- CK-MB Values(During the first 24 hours following myocardial reperfusion)
- Defibrillation rate(During surgery)