Actively Recruiting
Study of Organ Perfusion in Heart Transplantation in Children
Led by Dr. F. Köhler Chemie GmbH · Updated on 2026-01-30
15
Participants Needed
3
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Organ Perfusion in Heart Transplantation in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from birth to less than 18 years
- Recipients awaiting their first heart transplant
- Ability of the patient or legal guardian to understand the trial and its consequences
- Written informed consent from the patient or legal guardian before enrollment
- Patient listed on the waiting list for heart transplantation
You will not qualify if you...
- Participation in any other interventional study within the last 30 days or ongoing
- History of severe organic disease other than heart disease
- History or presence of HIV antibodies or AIDS
- Undergoing multiorgan transplantation
- Organ preserved by machine perfusion
- Explantation team different from transplantation team
- Failing Fontan patients
- Patients incarcerated or involuntarily institutionalized by court or authorities
- Pregnancy or lactation
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Deutsches Herzzentrum der Charité
Berlin, Germany, 13353
Actively Recruiting
2
Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie
Giessen, Germany, 35385
Actively Recruiting
3
Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische Klinik
München, Germany, 81377
Actively Recruiting
Research Team
R
Roman Petrov, Dr.
CONTACT
K
Kathleen Steyrer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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