Study of Organ Perfusion in Heart Transplantation in Children

Last updated: August 27, 2024
Sponsor: Dr. F. Köhler Chemie GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Heart Transplantation

Treatment

Custodiol

Custodiol-N

Clinical Study ID

NCT06032195
CL-N-HTX-Paed-II/10/20
  • Ages 24-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andindividual consequences of the clinical trial

  • written informed consent of the patients and/ or their legal guardians (must beavailable before enrolment in the study)

  • Patient listed on the waiting list for heart transplantation

Exclusion

Exclusion Criteria:

  • Patients who have participated within 30 days or are still participating in anyother 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 courtorder or by the authorities

  • Pregnancy and lactation

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Custodiol
Phase: 2
Study Start date:
August 15, 2023
Estimated Completion Date:
December 31, 2025

Study 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 orthotopic heart transplantation are essentially the same in adult and paediatric patients . Due to anatomical variants in congenital heart disease the procurement procedure may be modified with regard to the extent of the Vena cava superior and the great vessels. In implantation most frequently the bicaval technique is used but the biatrial technique which is leaving the back wall of both atria in situ may also be employed.

A main difference between adult and paediatric heart transplantation (HTx) are the indications for transplantation: In adults the majority of patients undergo HTx as treatment of end stage heart failure due to cardiomyopathy or severe coronary artery disease when other treatments have failed. Infants younger than one year of age congenital heart disease (CHD) is the most common diagnosis representing more than every second case followed by dilated cardiomyopathy (DCM) in more than one third of cases. In older patients DCM is the most frequent underlying diagnosis. CHD may include patients who have undergone corrective surgery and in whom myocardial dysfunction develops later .

Connect with a study center

  • Deutsches Herzzentrum der Charité

    Berlin, 13353
    Germany

    Active - Recruiting

  • Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie

    Gießen, 35385
    Germany

    Active - Recruiting

  • Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische Klinik

    München, 81377
    Germany

    Active - Recruiting

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