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Study of Organ Perfusion in Heart Transplantation in Children
Sponsor: Dr. F. Köhler Chemie GmbH
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.
Official title: A Prospective Randomized Single Blind Multicenter Phase II Study of Organ Perfusion With Custodiol-N Compared With Custodiol in Heart Transplantation in Children
Key Details
Gender
All
Age Range
24 Hours - 17 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2023-08-15
Completion Date
2027-09
Last Updated
2026-01-30
Healthy Volunteers
No
Conditions
Interventions
Custodiol-N
heart will preserved in and will be treated with Custodiol-N solution
Custodiol
heart will preserved in and will be treated with Custodiol solution
Locations (3)
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