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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001112-29 | EudraCT Number |
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The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custodiol-N | Experimental | comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation |
|
| Custodiol | Active Comparator | comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custodiol-N | Drug | comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Creatine kinase Myocard type "CK-MB" peak value | day 1: measurements 4, 8, 12, 16, 20, 24 hours ± 30 min; day 2-3: measurements 8, 16 and 24 hours ± 2 hours; day 4-7 one time/day | from 4 to 168 hours after release of the aortic cross clamp |
| Measure | Description | Time Frame |
|---|---|---|
| Catecholamine requirement | defined as "yes" or "no" | from entry to the trial up to day 7 |
| Patient survival | at 7 days and 1, 3 and 12 months |
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Inclusion Criteria:
Donor criteria:
Exclusion Criteria:
Donor criteria:
Patient criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabor Szabo, Prof. Dr. | Abt. Herzchirugie, Universitätsklinikum Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Chirurgie-Klin. Abteilung für Herzchirurgie, MUW-AKH Wien | Vienna | 1090 | Austria | |||
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| Custodiol | Drug | comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation |
|
| organ perfusion for heart transplantation | Procedure |
|
| Complications | occurrence, severity, type, and duration | from the time of the transplantation up to day 7 |
| Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW |
| Bad Oeynhausen |
| 32545 |
| Germany |
| Klinik für Herz-, Thorax- und Gefäßchirurgie, Deutsches Herzzentrum Berlin | Berlin | 13353 | Germany |
| Klinik für Kardiovaskuläre Chirurgie, Universitätsklinikum Düsseldorf | Düsseldorf | 40225 | Germany |
| Klinik für Herz- und Gefäßchirurgie, Universitätszentrum Freiburg Bad Krotzingen | Freiburg im Breisgau | 79106 | Germany |
| Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg | Hamburg | 20246 | Germany |
| Abt. Herzchirugie, Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena | Jena | 07747 | Germany |
| Herz- Thorax- und herznahe Gefäßchirurgie, Klinikum der Universität Regensburg | Regensburg | 93042 | Germany |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549285 | Custodiol-N solution |
| D016027 | Heart Transplantation |
| ID | Term |
|---|---|
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
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