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

Dr. Franz Köhler Chemie

Status and phase: Completed; Phase 3

Conditions: Heart Failure

Treatments: Procedure: organ perfusion for heart transplantation; Drug: Custodiol; Drug: Custodiol-N

Study type: Interventional

Funder types: Industry

Identifiers

NCT02869022

CL-N-HTX-CSM-III/04/12

2012-001112-29 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 105 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 2 patient groups

Custodiol-N

Experimental group

Description:

comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation

Treatment:

Procedure: organ perfusion for heart transplantation

Drug: Custodiol-N

Custodiol

Active Comparator group

Description:

comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation

Treatment:

Procedure: organ perfusion for heart transplantation

Drug: Custodiol