NCT06032195 Study of Organ Perfusion in Heart Transplantation in Children
| NCT ID | NCT06032195 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Dr. F. Köhler Chemie GmbH |
| Condition | Heart Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-08-15 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 15 participants in total. It began in 2023-08-15 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Christoph Knosalla, Prof. Dr.
PRINCIPAL INVESTIGATOR
Deutsches Herzzentrum der Charité
Frequently Asked Questions
Who can join the NCT06032195 clinical trial?
This trial is open to participants of all sexes, aged 24 Hours or older, up to 17 Years, studying Heart Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06032195 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06032195 currently recruiting?
Yes, NCT06032195 is actively recruiting participants. Contact the research team at r.petrov@koehler-chemie.de for enrollment information.
Where is the NCT06032195 trial being conducted?
This trial is being conducted at Berlin, Germany, Giessen, Germany, München, Germany.
Who is sponsoring the NCT06032195 clinical trial?
NCT06032195 is sponsored by Dr. F. Köhler Chemie GmbH. The principal investigator is Christoph Knosalla, Prof. Dr. at Deutsches Herzzentrum der Charité. The trial plans to enroll 15 participants.