Medical conditions with the need for 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/infusion
INN or Proposed INN: Not available
CAS Number: 7447-40-7
Current Sponsor code: Not applicable
Other de
Sponsors
Swiss Cardio Technologies AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Number of major deviations from the application of Cardioplexol as determined by the pre-specified training documentation. The primary endpoint for each patient is fulfilled only if the application of Cardioplexol TM is correct in all below described points or if deviations are explained. - Correct volume of initial dose - Correct duration of injection of initial dose - Correct timing of application of initial dose - Correct volume of second/third/fourth dose - Correct timing of application of second/third/fourth dose;Main Objective: The main objective is to explore the effects of a training program on the rate of correct application of Cardioplexol for cardioplegic cardiac arrest during cardiac surgical interventions.;Secondary Objective: The secondary objectives are: - 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. - to explore the effects on duration in Intensive Care Unit (ICU) stay and on duration of hospitalization. - to evaluate the safety and tolerability of Cardioplexol.;Timepoint(s) of evaluation of this end point: During the surgical procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evolution of TnT values during the first 24 hours following myocardial reperfusion. - Evolution of CK-MB values during the first 24 hours following myocardial reperfusion. - Time between the aortic cross-clamping and the complete cardiac arrest. - Cumulative dose of catecholamines during aortic cross-clamping. - Defibrillation rate after aorta unclamping and coronary reperfusion. - Cumulative dose of catecholamines during the first 24 hours following coronary reperfusion, starting calculation at ICU arrival. - Duration of ICU stay. - Mortality during the first 24 hours following coronary reperfusion - Safety (SAEs and AEs, Lab Parameters);Timepoint(s) of evaluation of this end point: During the first 24 hours following coronary reperfusion or until ICU discharge (if discharge occurs before 24 hours). Safety is evaluated up to 30 days after the end of the surgery. | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactHendrik Tevaearai Stahel
Testa Logic GmbH
Outcome results
None listed