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

• Status: Completed
• Trial end date: 2019-09-02
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. F. Köhler Chemie GmbH
• Treatments: Pharmaceutical Solutions

Criteria

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