Clinical Trial

Study of Organ Perfusion in Heart Transplantation in Children

Recruiting Phase 2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-09-08; most recent amendment 2026-01-28.
Status change: Active, Not Recruiting → Recruiting 2024-08-27
Trial Details
NCT Number NCT06032195
Lead Sponsor Dr. F. Köhler Chemie GmbH
Conditions Heart Transplantation
Enrollment 15 participants
Start Date 2023-08-15
Primary Completion 2027-01 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-01-30