Study of Organ Perfusion in Heart Transplantation in Children

Launched by DR. F. KÖHLER CHEMIE GMBH · Sep 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different solutions used to preserve hearts before they are transplanted into children. The main goal is to see if a new solution called Custodiol-N is safe to use compared to an older solution called Custodiol. Researchers want to know if using Custodiol-N can help ensure that the heart remains healthy and functional during the transplant for children who are waiting for their first heart transplant.

To join the trial, participants need to be under 18 years old and must be on the waiting list for a heart transplant. They should also be able to understand the study and give consent, or have a legal guardian who can do so on their behalf. If chosen for the study, participants will receive either a heart preserved with Custodiol-N or Custodiol, and their health will be monitored closely to ensure the safety of the new solution. It’s important to note that certain conditions, like severe other health issues or being part of another study recently, might prevent someone from participating.

Gender

ALL

Eligibility criteria

• 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 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 Criteria:
• • 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