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Clinical Trials in Germany / NCT06032195
Recruiting Phase 2

Study of Organ Perfusion in Heart Transplantation in Children

NCT06032195 · tracked via the Priya Life Science Germany tracker
Sponsor
Dr. F. Köhler Chemie GmbH
Phase
Phase 2
Started
2023-08-15
Last updated
2026-01-30

Condition(s) studied

Heart Transplantation

Investigational drug(s) / intervention(s)

Custodiol-N →Custodiol →

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

Custodiol: heart will preserved in and will be treated with Custodiol solution

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.

Eligibility

Sex
ALL
Min age
24 Hours
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Age from birth to less than18 years * Recipients awaiting their first transplant * Ability of the patients and/ or their legal guardians to understand character and individual consequences of the clinical trial * written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study) * Patient listed on the waiting list for heart transplantation Exclusion Criteria: * Patients who have participated within 30 days or are still participating in any other interventional studies * history of severe organic disease other than concerning the heart * history/demonstration of HIV antibodies or AIDS * multiorgan transplantation * machine-perfused organ * the explantation team is affiliated to another clinic than transplantation team * Failing Fontan patients * Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities * Pregnancy and lactation

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Deutsches Herzzentrum der Charité Berlin Germany Recruiting
Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie Giessen Germany Recruiting
Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische Klinik München Germany Recruiting

Other trials for the same condition

METABolic Deterioration in HTX Determines Outcomes Recruiting
Genomics in Heart Transplants Starting soon
Multimodal Analysis of Endomyocardial Biopsies Recruiting
Non-ischemic Preservation of the Donor Heart in Heart Transplantation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06032195 on ClinicalTrials.gov ↗ ← All trials in Germany