A multi-center, open label, single group, observational study to investigate the effects of training on the administration of Cardioplexol (TM)?

Swiss Cardio Technologies AG0 个研究点目标入组 165 人开始时间: 2019年1月2日最近更新: 2022年1月10日

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 will be carried out via a full or a hemi sternotomy, under cardiac arrest and under the assistance of a heart lung machine;
•4. Patients 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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 105

•1. Pre-operative EF of less than 30%;
•2. Pre-operative IABP;
•3. 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. Aortic valve insufficiency severity grade > 1;
•8. Under dialysis;
•9. Pre-operative serum creatinine value of more than 2.0 mg/dl;
•10. Known hematologic disorder;
•11. Previous therapeutic treatment with anti-vitamin K within 5 days before surgery, or with thrombin inhibitors or factor Xa inhibitors within 3 days before surgery;
•12. History of HIT;
•13. Participating in a concomitant research study of an investigational product;
•14. Pregnant or lactating;
•15. Intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent.

发起方