Status:
RECRUITING
Study of Organ Perfusion in Heart Transplantation in Children
Lead Sponsor:
Dr. F. Köhler Chemie GmbH
Conditions:
Heart Transplantation
Eligibility:
All Genders
24-17 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Orthotopic Heart transplantation (or cardiac transplantation) is a procedure performed in patients with end stage heart failure when other treatments have failed. The surgical procedures for orthotop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06032195
Start Date
August 15 2023
End Date
December 1 2025
Last Update
August 28 2024
Active Locations (3)
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1
Deutsches Herzzentrum der Charité
Berlin, Germany, 13353
2
Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie
Giessen, Germany, 35385
3
Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische Klinik
München, Germany, 81377