Medical conditions necessitating an elective surgical coronary artery bypass grafting (CABG) and/or a valve repair/replacement.
Conditions
Interventions
Product Name: Cardioplexol
Product Code: Cpx
Pharmaceutical Form: Solution for injection
Sponsors
Swiss Cardio Technologies AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the effects of Cardioplexol on the protection of cardiac cells during the “ischemic” period in order to allow a rapid and complete reversibility of the cardiac arrest when used during a cardiac surgical intervention under the assistance of a heart-lung machine. ;Secondary Objective: To explore the effects on duration in ICU stay and on duration of hospitalisation To evaluate the safety and tolerability of Cardioplexol ;Primary end point(s): Maximal value of troponin-T (ng/ml) during the first 24 hours following myocardial reperfusion.;Timepoint(s) of evaluation of this end point: 6, 12, 24, hours after myocardial reperfusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Maximal value of CK-MB during the first 24 hours following myocardial reperfusion. 2. Time between the aortic cross-clamping and the complete cardiac arrest. 3. Percentage of patients requiring catecholamines during aortic cross-clamping. 4. Cumulative dose of catecholamines during aortic cross-clamping. 5. Defibrillation rate after aorta unclamping and coronary reperfusion. 6. Cumulative dose of catecholamines during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). 7. Percentage of patients requiring the installation of an IABP during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). 8. Duration of intubation. 9. Duration of ICU stay. 10. Mortality during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). 11. Maximal ST elevation during the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). 12. Duration of hospitalization. ;Timepoint(s) of evaluation of this end point: Most secondary endpoints are measured during surgery or during the first 24 hours following myocardial reperfusion (details are described under E.5.2) | — |
Countries
Austria
Contacts
Public ContactHendrik Tevaearai
Swiss Cardio technologies AG
Outcome results
None listed