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Study identifier: NCT06032195 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Study of Organ Perfusion in Heart Transplantation in Children

Condition: Heart Transplantation  ·  Sponsor: Dr. F. Köhler Chemie GmbH

PhasePhase 2
Planned participants15
Who can joinAll sexes, 24 Hours to 17 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Roman Petrov, Dr.  ·  + 49-6251-1083  ·  r.petrov@koehler-chemie.de

Kathleen Steyrer  ·  +49-6221-56  ·  kathleen.steyrer@med.uni-heidelberg.de

Always discuss trial participation with your own doctor first.

Locations (3)

Deutsches Herzzentrum der CharitéBerlin, GermanyRecruiting
Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für KinderherzchirurgieGiessen, GermanyRecruiting
Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische KlinikMünchen, GermanyRecruiting

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Source record: clinicaltrials.gov/study/NCT06032195