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)
- Conditions
- heart transplantation in childrenTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-510492-57-00
- Lead Sponsor
- Dr. Franz Koehler Chemie GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method