Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation

Study Overview
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Brief Summary
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The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.

Official Title
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A Prospective, Randomized, Single Blind, Multicenter Phase III Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Custodiol-N
* Drug: Custodiol
* Procedure: organ perfusion for heart transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Custodiol-N<br>comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation | Drug: Custodiol-N<br>* comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation<br>Procedure: organ perfusion for heart transplantation<br> <br> |
| Active Comparator: Custodiol<br>comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation | Drug: Custodiol<br>* comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation<br>Procedure: organ perfusion for heart transplantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Complications | occurrence, severity, type, and duration | from the time of the transplantation up to day 7 |