Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open label, single group, observational study designed to evaluate the effects of a Cardioplexol™ preparation and administration training program proposed to cardiac surgeons and cardiotechnicians inexperienced in the use of Cardioplexol™. The training program aims at increasing the efficacy of Cardioplexol administration while reducing the risk of false manipulations. During the training possible risks and consequences of incorrect applications as well as the measures to take in case of administration error, are discussed. The training program includes one standardized theoretical part and one practical part consisting of a direct intra-operative coaching of surgeons practicing their first 2 operations. The effect of the training will then be assessed by evaluating each trained surgeon's 4 next consecutive patients operated with Cardioplexol and without the coach.

Official Title
-----------------
A Multi-Center, Open Label, Single Group, Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™

Conditions
-----------------
Coronary Artery Bypass Surgery, Valve Surgery

Intervention / Treatment
-----------------
* Drug: Cardioplegia Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients between 18 and 80 years of age; The patient's pre-operative evaluation indicates the need for a primary elective cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve repair/replacement; The operation can be carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine; Patients who provide signed written informed consent. Exclusion Criteria: Pre-operative EF of less than 30%; Pre-operative IABP; Pre-operative catecholamine support; History of myocardial infarction within less than 7 days; Previous history of cardiac surgery, including the implantation of a pace maker or an ICD; Active myocarditis and/or endocarditis; Aortic valve insufficiency severity grade more than 1; Under dialysis; Pre-operative serum creatinine value of more than 2.0 mg/dl; Known hematologic disorder; Treatment with anti-vitamin K; History of HIT; Participating in a concomitant research study of an investigational product; Pregnant or lactating; Intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardioplexol™- Cardioplegia Solution<br>Cardioplexol™ will be used as cardioplegic solution in cardiac surgery | Drug: Cardioplegia Solution<br>* Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution<br>* Other names: Cardioplexol™;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Deviation in Cardioplexol application | Number of major deviations from the application of Cardioplexol™ as determined by the pre-specified training documentation (incorrect volume of initial dose, incorrect volume of second/third/fourth dose, incorrect duration of injection of initial dose, incorrect timing of application of initial dose, incorrect timing of application of second/third/fourth dose). | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TnT Values | Development of concentration of blood Troponin T values measured by the local hospital laboratory | During the first 24 hours following myocardial reperfusion | 
| CK-MB Values | Development of concentration of blood Creatin Kinase - isoenzyme MB (muscle-brain) values measured by the local hospital laboratory | During the first 24 hours following myocardial reperfusion | 
| Complete Cardiac Arrest | Time between the aortic cross-clamping and the complete cardiac arrest | During Surgery | 
| Catecholamine | Cumulative dose of catecholamines | During during aortic cross-clamping and during the first 24 hours | 
| Defibrillation rate | Defibrillation rate after aorta unclamping and coronary reperfusion. | During surgery | 
| ICU stay | Duration of ICU stay | During follow-up phase after surgery up to 35 days | 
| Mortality | Number of patients, who died | During the first 24 hours following coronary reperfusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardioplegic Solutions