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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardioplexol™- Cardioplegia Solution | Experimental | Cardioplexol™ will be used as cardioplegic solution in cardiac surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardioplegia Solution | Drug | Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik Innsbruck | Innsbruck | 6020 | Austria | |||
| Universitaetsklinikum Salzburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40491721 | Derived | Tevaearai Stahel HT, Taheri N, Winkler A, Hohlfeld J, Dietl W, Starck C, Van Linden A, Bidovec J, Imhof A, Carrel TP, Voet B, Walther T, Seitelberger R, Grimm M, Holzinger C, Grabenwoger M. A multi-center, open label, single group, observational clinical trial to investigate the effects of training on the administration of Cardioplexol. Front Cardiovasc Med. 2025 May 26;12:1588088. doi: 10.3389/fcvm.2025.1588088. eCollection 2025. |
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| ID | Term |
|---|---|
| D002314 | Cardioplegic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002317 | Cardiovascular Agents |
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| 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 |
| Salzburg |
| 5020 |
| Austria |
| Universitaetsklnikum St. Pölten | Sankt Pölten | 3100 | Austria |
| Krankenhaus Hietzing | Vienna | 1130 | Austria |
| Deutsches Herzzentrum Berlin | Berlin | 13353 | Germany |
| Universitaetsklinikum Frankfurt | Frankfurt | 60590 | Germany |
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |