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New treatment option for Heart Transplantation
Official title Study of Organ Perfusion in Heart Transplantation in Children
ClinicalTrials.gov ID: NCT06032195
What this study is testing
What is Custodiol-N?
Custodiol-N is an investigational medicine, being studied as a potential treatment for heart transplantation.
Also referred to as Solution for organ preservation in transplantation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 24 to 17
You may be able to join if
- 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
You likely can't join if
- Patients who have participated within 30 days or are still participating in any other treatment 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
See the full eligibility 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
- Patients who have participated within 30 days or are still participating in any other treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Giessen, Germany
- München, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 24 hours to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany; Giessen, Germany; München, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.