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Study comparing Custodiol-N and Custodiol organ preservation solutions for heart transplantation in children

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying two organ preservation solutions, Custodiol and Custodiol-N, in children undergoing heart transplantation. These solutions are special liquids used to protect and preserve donor hearts during the transplant procedure. The study aims to compare the safety of these two solutions when used in children receiving their first heart transplant.

During the transplant procedure, either Custodiol or Custodiol-N will be used to preserve the donor heart. Both solutions contain various substances that help protect the heart tissue while it is being transferred from the donor to the recipient. The solution is administered through a process called infiltration, where it is carefully introduced into the heart tissue.

After the transplant, doctors will monitor the children's health for three months. They will check important health indicators like heart rate and blood pressure, perform blood tests, and watch for any complications. The study will also track how long children need to stay in the intensive care unit, whether they need heart support medications, and how well their new heart is functioning.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial phase after transplant
During heart transplantation, one of two preservation solutions will be used: Custodiol-N or Custodiol
After the transplant procedure, you will be transferred to the Intensive Care Unit (ICU)
Your vital signs including heart rate, blood pressure, and body temperature will be monitored regularly for 7 days
Step 2
Medical tests - first week
Blood tests will be performed to measure heart-related proteins (cardiac troponin and CK-MB) for the first 7 days
Heart function will be checked using ultrasound (echocardiogram) to assess how well the new heart is working
Your heart rhythm will be monitored to detect any irregular heartbeats
If needed, you may receive medications to support heart function or control blood pressure
Step 3
Ongoing monitoring - first month
Regular blood tests will continue to check your general health and heart function
Your medical team will monitor for any complications or side effects
The length of stay in the ICU will be recorded
Step 4
Extended follow-up - up to 3 months
Regular check-ups will continue for 3 months after the transplant
Any hospital readmissions or returns to ICU will be documented
The medical team will track the success of the transplant and any complications
The study will conclude after the 3-month follow-up period

Who can join the trial?

7 criteria

Must be between birth and 17 years of age
Must be waiting for their first heart transplant (no previous transplants)
Patient and/or their legal guardians must be able to understand the nature and consequences of participating in the clinical trial
Patient and/or their legal guardians must provide written informed consent before joining the study
Must be officially registered on the heart transplant waiting list
The organ donor must meet standard criteria for organ donation (requirements that ensure the donated organ is suitable for transplantation)
Both male and female patients can participate in the study

Who cannot join the trial?

11 criteria

Patient age outside the range of 2-11 years old
Previous organ transplant surgeries
Active infections that could affect surgery outcomes
Severe allergic reactions to medications used in organ preservation
Conditions that make heart transplantation too risky, such as severe lung problems
Inability to follow post-transplant care instructions
Participation in other clinical trials within the last 30 days
Parents or legal guardians unable to provide informed consent
Known allergies to Custodiol or Custodiol-N (organ preservation solutions used during transplant)
Medical conditions that could interfere with the study results
Inability to attend required follow-up visits for 3 months after surgery

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Charite Universitaetsmedizin Berlin KöR
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Berlin, Germany
Justus-Liebig-Universitaet Giessen
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Giessen, Germany
Klinikum der Universitaet Muenchen AöR
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Munich, Germany

Trial locations

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Investigated drugs

Custodiol is a preservation solution used during heart transplantation procedures. It helps protect and preserve the donor heart during transportation and before transplantation by maintaining the organ's condition and reducing potential damage. Custodiol-N is a newer version of the preservation solution used for protecting donor hearts during transplantation. Like the original Custodiol, it is designed to keep the donor heart viable during transport and before transplantation, but it may have improved protective properties. Both solutions are used specifically in pediatric heart transplantation procedures to help ensure the donated heart remains in the best possible condition until it can be transplanted into the recipient child.

What is already known about the treatment

Custodiol
An organ preservation solution primarily used during heart transplantation procedures, specifically designed to protect donor hearts during transportation and storage. This sterile solution is administered by perfusion of the donor organ and works by preventing cellular damage and maintaining tissue viability through its unique combination of electrolytes and buffer systems. As a standard-of-care preservation solution in transplant medicine, Custodiol helps reduce ischemic injury and extends the safe preservation time of cardiac tissue, making it essential in pediatric heart transplantation procedures.
Custodiol-N
An advanced organ preservation solution that represents a new generation of cardiac protection during transplantation procedures. This solution is administered through organ perfusion and contains enhanced protective compounds compared to standard Custodiol, designed to provide better protection against ischemia-reperfusion injury. Custodiol-N is currently being evaluated in clinical trials for pediatric heart transplantation to assess its safety profile and potential advantages over conventional preservation solutions, with the aim of improving transplant outcomes in children.

Investigated diseases

End-stage Heart Failure Requiring Transplantation in Children
A serious cardiac condition where the heart muscle becomes too weak to effectively pump blood to meet the body's needs in pediatric patients. The condition progressively worsens over time, affecting the child's ability to perform normal daily activities. The heart's decreased function leads to various symptoms including fatigue, difficulty breathing, and reduced exercise tolerance. This condition develops when other heart problems have progressed to a severe state or due to congenital heart defects. The weakened heart function impacts other organ systems due to inadequate blood circulation. The condition reaches a point where heart transplantation becomes necessary for survival.
Heart Transplant Rejection
A condition where the recipient's immune system recognizes the transplanted heart as foreign and attempts to attack it. The process can begin within days to weeks after transplantation. The immune response can cause inflammation and damage to the heart tissue. Rejection can occur at different levels of severity, from mild to severe. The body's response to the new organ can affect how well the transplanted heart functions.