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Study of Organ Perfusion in Heart Transplantation in Children

RecruitingPhase 2Ages 24 Hours - 17 YearsAllDr. F. Köhler Chemie GmbH
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Custodiol-N
  • Custodiol
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Where

3 sites
Deutsches Herzzentrum der Charité
Berlin, Germany
Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie
Giessen, Germany
Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische Klinik
München, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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