The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation
comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation
Universitätsklinik für Chirurgie-Klin. Abteilung für Herzchirurgie, MUW-AKH Wien
Vienna, Austria
Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Klinik für Herz-, Thorax- und Gefäßchirurgie, Deutsches Herzzentrum Berlin
Berlin, Germany
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
Time frame: from 4 to 168 hours after release of the aortic cross clamp
Catecholamine requirement
defined as "yes" or "no"
Time frame: from entry to the trial up to day 7
Patient survival
Time frame: at 7 days and 1, 3 and 12 months
Complications
occurrence, severity, type, and duration
Time frame: from the time of the transplantation up to day 7
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Klinik für Kardiovaskuläre Chirurgie, Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Klinik für Herz- und Gefäßchirurgie, Universitätszentrum Freiburg Bad Krotzingen
Freiburg im Breisgau, Germany
Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg
Hamburg, Germany
Abt. Herzchirugie, Universitätsklinikum Heidelberg
Heidelberg, Germany
Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena
Jena, Germany
Herz- Thorax- und herznahe Gefäßchirurgie, Klinikum der Universität Regensburg
Regensburg, Germany