A Single-Centre, Single Blind, Randomized, Active-Controlled Phase III Non-Inferiority Study to Investigate the Safety and Efficacy of the Cardioplegic Solution Cardioplexol? when used during a Cardiac Surgical Intervention under the Assistance of a Heart-Lung Machine

Swiss Cardio Technologies AG0 个研究点目标入组 264 人开始时间: 2011年10月4日最近更新: 2022年3月28日

适应症

试验速览

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•1. Male or female patients between 18 and 80 years of age.
•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 can be carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine;
•4. Patients (or legal representatives) who provide signed written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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