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A prospective randomized single blind multicenter phase II study of organ perfusion with Custodiol-N compared with Custodiol in heart transplantation in children (CL-N-HTX-Paed-II/10/20)
EU CTIS ID: 2023-510492-57-00
What this study is testing
The objective of this investigation is to compare the safety of two organ preservation solutions,Custodiol and Custodiol-N, in paediatric patients undergoing heart transplantation Primary: Safety assessment, i.e. continuous adverse event reporting up to 3 months
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient criteria: Age from birth to less than18 years
- Patient critera: Recipients awaiting their first transplant
- Patient criteria: Ability of the patients and/ or their legal guardians to understand character and individual consequences of the clinical trial
- Patient criteria: written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study)
- Patient criteria: Patient listed on the waiting list for heart transplantation
- Donor criteria: deceased donors should fulfil the standard criteria for organ donation (SCD)
You likely can't join if
- 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
See the full eligibility criteria
- Patient criteria: Age from birth to less than18 years
- Patient critera: Recipients awaiting their first transplant
- Patient criteria: Ability of the patients and/ or their legal guardians to understand character and individual consequences of the clinical trial
- Patient criteria: written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study)
- Patient criteria: Patient listed on the waiting list for heart transplantation
- Donor criteria: deceased donors should fulfil the standard criteria for organ donation (SCD)
- 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
- Pregnancy and lactation
- Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.