Study of Organ Perfusion in 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
Dr. F. Köhler Chemie GmbH
15 participants
Aug 15, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria9
- 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
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Interventions
heart will preserved in and will be treated with Custodiol-N solution
heart will preserved in and will be treated with Custodiol solution
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06032195