Study of Organ Perfusion in Heart Transplantation in Children
ConditionHeart Transplantation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age24-17
SponsorDr. F. Köhler Chemie GmbH
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Custodiol-N
- Custodiol
Treatment groups
15 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov