Comparing two solutions for heart transplantation in children
A Prospective Randomized Single Blind Multicenter Phase II Study of Organ Perfusion With Custodiol-N Compared With Custodiol in Heart Transplantation in Children
This study is testing a new heart preservation solution called Custodiol-N to see if it is safer than the older version, Custodiol, for children getting their first heart transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 24 Hours to 17 Years |
| Sex | All |
| Sponsor | Dr. F. Köhler Chemie GmbH Industry-sponsored |
| Locations | 3 sites (Berlin and 2 other locations) |
| Trial ID | NCT06032195 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to evaluate the safety of Custodiol-N compared to its predecessor, Custodiol, in heart transplantation for children under 18 years old. The study is prospective, randomized, and single-blind, involving multiple centers. Participants will receive a heart perfused with either Custodiol-N or Custodiol, and researchers will assess the safety of the new solution. The trial focuses on children awaiting their first heart transplant, addressing the unique challenges of pediatric heart transplantation.
Who should consider this trial
Good fit: Ideal candidates are children from birth to less than 18 years old who are listed for their first heart transplant.
Not a fit: Patients with severe organic diseases unrelated to the heart or those undergoing multiorgan transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and outcomes of heart transplantation in children.
How similar studies have performed: While this approach is novel in the context of pediatric heart transplantation, similar studies in adult populations have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Berlin and 2 other locations
- 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)
Study contacts
- Principal investigator: Christoph Knosalla, Prof. Dr. — Deutsches Herzzentrum der Charité
- Study coordinator: Roman Petrov, Dr.
- Email: r.petrov@koehler-chemie.de
- Phone: + 49-6251-1083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.