Study of Organ Perfusion in Heart Transplantation in Children
Status:
RECRUITING
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
The goal of this prospective randomized single blind multicenter phase II study is to compare organ perfusion with Custodiol-N and Custodiol in heart transplantation in children of all ages (birth to \<18 years) being listed on the waiting list for heart transplantation. The main question it aims to answer is:
to compare the safety of Custodiol-N in heart transplantation in children in comparison to its precursor product Custodiol.
Participants will receive either a heart to be transplanted, either perfused with Custodiol-N or Custodiol to Researchers will compare the two solutions to see if the new solution Custodiol-N is safe in heart transplantation in children.
Phase:
PHASE2
Details
Lead Sponsor:
Dr. F. Köhler Chemie GmbH
Treatments:
Custodiol-N solution Organ Preservation Solutions Transplantation