E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Medical conditions with the need for an elective surgical coronary artery bypass grafting (CABG) and/or a valve repair/replacement . |
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E.1.1.1 | Medical condition in easily understood language |
Medical condition requiring a cardiac surgical Intervention. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the surgical procedure |
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E.5.2 | 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) |
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E.5.2.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Investigate the Effects of Training on the Administration of Cardioplexol |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Germany |
Switzerland |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |