Study of Organ Perfusion in Heart Transplantation in Children
This study is comparing two special liquids, Custodiol-N and Custodiol, which are used to keep a heart healthy when it's being transported for a transplant operation. The main goal is to find out if the newer liquid, Custodiol-N, is safe for children who are having a heart transplant. The study involves children from birth up to 17 years old who are waiting for a new heart. Participants will receive a heart that has been prepared with either Custodiol-N or Custodiol. Doctors will then observe the children to see how well they do with the heart preserved by each liquid. This is an important step to make sure new medical solutions are safe and effective for young patients.
At a glance
What is this study about?
When a child needs a heart transplant, it's a very serious operation done when their own heart can no longer work properly after other treatments have failed. This can be because of problems they were born with (congenital heart disease) or other heart conditions like cardiomyopathy.
During a heart transplant, the donor heart needs to be carefully preserved while it's transported from the donor to the child receiving it. Special cold liquids, called perfusion solutions, are used for this. They help keep the heart healthy and in good condition before the surgery. This study is testing a newer liquid, Custodiol-N, against an older, well-known one, Custodiol. The main aim is to check if Custodiol-N is just as safe and effective as Custodiol when used for children's heart transplants.
Doctors want to make sure that any new treatment or method is as safe as possible, especially for children. By comparing these two solutions, they hope to learn more about how well Custodiol-N works and if it can be a good option for protecting the hearts of young patients needing a transplant.
Key takeaways
- This study compares two heart preservation liquids: Custodiol-N and Custodiol.
- The main goal is to check if Custodiol-N is safe for children's heart transplants.
- It involves children from birth up to 17 years old who need a new heart.
- Participation will not change your child's standard transplant care.
- Your child will receive a heart preserved with one of the two solutions, decided randomly.
- The study aims to improve future heart transplant options for children.
Who may be eligible?
To be part of this study, a child must be less than 18 years old, from a newborn baby up to 17 years. They need to be waiting for their very first heart transplant. It's also important that the child (if old enough) and/or their parents or legal guardians understand what the study involves and agree to take part by signing a consent form.
However, some children might not be able to join. For example, if they have recently taken part in another medical study within the last month or are still in one. Also, children with other serious health problems unrelated to their heart, or those who have HIV/AIDS, cannot participate. Children needing more than one organ transplant or where the heart was prepared with a special machine are also not included.
Additionally, if a child has a specific heart condition called 'failing Fontan' or if they are pregnant or breastfeeding, they would not be eligible. The study also cannot include children who have been in prison or placed in an institution by court order.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is my child under 18 years old?
- Is my child waiting for their first heart transplant?
- Do I (and my child, if old enough) understand the study and agree to take part?
- Has my child NOT been in another study in the last month?
- Does my child NOT have any other severe diseases besides their heart condition?
- Is my child NOT pregnant or breastfeeding?
What does participation involve?
If your child takes part in this study, they will be given a heart for their transplant that has been prepared using either Custodiol-N or Custodiol. You and your child won't know which solution was used, but the doctors caring for them will. After the transplant, the doctors will regularly check your child's health, as they normally would, to see how well the new heart is working and how they are recovering. The study will mainly involve doctors collecting information from your child's standard medical care. There are no additional hospital visits or tests specifically for the study beyond what your child would already receive as part of their transplant care. The total duration of participation would cover the transplant procedure and the usual follow-up care provided by the hospital.
Potential risks and benefits
Locations (3)
- Deutsches Herzzentrum der CharitéVerified postcodeBerlin, Germany· Recruiting
- Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für KinderherzchirurgieVerified postcodeGiessen, Germany· Recruiting
- Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische KlinikVerified postcodeMünchen, Germany· Recruiting
Common questions
What is 'Custodiol'?
Custodiol is a special liquid used to protect and keep a donor heart healthy while it's being transported for a transplant.
Why are they studying this liquid?
Doctors want to compare a newer version, Custodiol-N, with the existing Custodiol, to make sure it's safe for children having heart transplants.
Will my child definitely get Custodiol-N?
No, your child will receive a heart preserved with either Custodiol-N or Custodiol, decided randomly by the study team.
Will taking part change my child's medical care?
No, your child will receive the same high standard of care they would normally get for a heart transplant, regardless of which liquid is used.
Who can join this study?
Children under 18 years old who are waiting for their first heart transplant and whose parents/guardians give permission.
How to find out more
Roman Petrov, Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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