Randomized Clinical Safety and Efficacy Investigation of the Swiss Cardio Technologies Cardioplexol? Solution in comparison with Buckberg Solution - Cardioplexol Study

Swiss Cardio Technologies AG0 个研究点目标入组 240 人开始时间: 2010年9月28日最近更新: 2012年3月19日

试验速览

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•1.The patient is between the age of 18 and 80;
•2.The patient’s preoperative evaluation indicates the need for a primary elective cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve repair/replacement;
•3.The operation is carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine;
•4.The patient has signed the Patient Informed Consent Form.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•1.pre-operative EF of less than 30%;
•2.pre-operative IABP;
•3.under pre-operative catecholamine support;
•4.history of myocardial infarction within less than 7 days;
•5.previous history of cardiac surgery, including the implantation of a pace maker or an ICD;
•6.active myocarditis and/or endocarditis;
•7.history of atrial fibrillation;
•8.aortic valve insufficiency severity grade > 1 ;
•9.history of neurologic event;
•10.carotid artery disease;
•11.renal insufficiency or is under dialysis;
•12.pre-operative serum creatinine value of more than 2.0 mg/dl;
•13.known for an hematologic disorder;
•14.under anti-vitamin K;
•15.history of HIT;
•16.participating in a concomitant research study of an investigational product;
•17.pregnant or lactating;
•18.intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent;

发起方