Heart Failure
Conditions
Brief summary
The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.
Interventions
DRUGCustodiol-N
comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation
DRUGCustodiol
comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation
PROCEDUREorgan perfusion for heart transplantation
Sponsors
Dr. F. Köhler Chemie GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Donor criteria: * deceased donors should fulfil the criteria for organ donation (SCD) Patient criteria * recipients awaiting their first transplant * recipients ≥ 18 and \>/= 65 years * recipient's signed informed consent * waiting list
Exclusion criteria
Donor criteria: * not applicable Patient criteria: * recipients participating in another interventional study * pregnant or lactating patients * history/demonstration of HIV antibodies or AIDS * multiorgan transplantation * transMedics pump * the explantation team is affiliated another clinic than transplantation team
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Creatine kinase Myocard type CK-MB peak value | from 4 to 168 hours after release of the aortic cross clamp | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catecholamine requirement | from entry to the trial up to day 7 | defined as yes or no |
| Patient survival | at 7 days and 1, 3 and 12 months | — |
| Complications | from the time of the transplantation up to day 7 | occurrence, severity, type, and duration |
Countries
Austria, Germany
Outcome results
None listed