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Study of Organ Perfusion in Heart Transplantation in Children

NCT06032195 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-30

No results posted yet for this study

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.

Conditions

  • Heart Transplantation

Interventions

DRUG

Custodiol-N

heart will preserved in and will be treated with Custodiol-N solution

DRUG

Custodiol

heart will preserved in and will be treated with Custodiol solution

Sponsors & Collaborators

  • Dr. F. Köhler Chemie GmbH

    lead INDUSTRY

Principal Investigators

  • Christoph Knosalla, Prof. Dr. · Deutsches Herzzentrum der Charité

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
24 Hours
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2027-01-31
Completion
2027-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06032195 on ClinicalTrials.gov