A Phase 2 interventional study of Custodiol-N and Custodiol in Heart Transplantation, sponsored by Dr. F. Köhler Chemie GmbH. Recruiting at 3 sites in Germany. Open to participants aged 24 Hours to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Dr. F. Köhler Chemie GmbH · Phase 2, Interventional, and Treatment
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.
Participants will receive either a heart to be transplanted, either perfused with Custodiol-N or Custodiol to Researchers will compare the two solutions to see if the new solution Custodiol-N is safe in heart transplantation in children.
Orthotopic Heart transplantation (or cardiac transplantation) is a procedure performed in patients with end stage heart failure when other treatments have failed.
The surgical procedures for orthotopic heart transplantation are essentially the same in adult and paediatric patients . Due to anatomical variants in congenital heart disease the procurement procedure may be modified with regard to the extent of the Vena cava superior and the great vessels. In implantation most frequently the bicaval technique is used but the biatrial technique which is leaving the back wall of both atria in situ may also be employed.
A main difference between adult and paediatric heart transplantation (HTx) are the indications for transplantation: In adults the majority of patients undergo HTx as treatment of end stage heart failure due to cardiomyopathy or severe coronary artery disease when other treatments have failed. Infants younger than one year of age congenital heart disease (CHD) is the most common diagnosis representing more than every second case followed by dilated cardiomyopathy (DCM) in more than one third of cases. In older patients DCM is the most frequent underlying diagnosis. CHD may include patients who have undergone corrective surgery and in whom myocardial dysfunction develops later .
Dr. F. Köhler Chemie GmbH is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
organ will be perfused with Custodiol-N solution
Drug: Custodiol-N
organ will be perfused with Custodiol solution
Drug: Custodiol
heart will preserved in and will be treated with Custodiol-N solution
Also known as: Solution for organ preservation in transplantation
heart will preserved in and will be treated with Custodiol solution
Also known as: Solution for organ preservation in transplantation
adverse event reporting
Safety assessment
Time frame: up to 3 months
heart rate
vital parameters
Time frame: up to day 7 after release of the aortic cross clamp
blood pressure (systolic (SBP) and diastolic (DBP))
vital parameters
Time frame: up to day 7 after release of the aortic cross clamp
body temperature
vital parameters
Time frame: up to day 7 after release of the aortic cross clamp
concentration of cardiac troponin
laboratory tests
Time frame: up to day 7 after release of the aortic cross clamp
concentration of creatinine kinase (CK-MB)
laboratory tests
Time frame: up to day 7 after release of the aortic cross clamp
(SBP (systolic blood pressure), DBP (diastolic blood pressure))
Haemodynamics
Time frame: from termination of cardiopulmonary bypass until transfer to intensive care unit
Heart Rhythm (HR)
Haemodynamics
Time frame: from termination of cardiopulmonary bypass until transfer to intensive care unit
Pulmonary artery pressure (PAP (if available))
Haemodynamics
Time frame: from termination of cardiopulmonary bypass until transfer to intensive care unit
Cerebrovascular resistance (CVP (if available))
Haemodynamics
Time frame: from termination of cardiopulmonary bypass until transfer to intensive care unit
Death
survival
Time frame: up to 12 months
function of transplanted organ (heart)
Graft survival
Time frame: up to 12 months
Readmission to intensive care unit (ICU)
return to intensive care unit
Time frame: up to 12 months
Length of ICU stays
duration of stay in intensive care unit
Time frame: up to 12 months
Catecholamine requirement
(yes/no)
Time frame: up to day 7
Antihypertensives intake
(yes/no)
Time frame: up to 12 months
Milrinone support
(yes/no)
Time frame: up to day 7
Need for pacemaker therapy
(yes/no)
Time frame: up to day 7
Left and right ventricular assist device (LVAD, RVAD)
Device therapy (each yes/no)
Time frame: up to 12 months
Extracorporeal membrane oxygenation (ECMO)
Device therapy (each yes/no)
Time frame: up to 12 months
Biventricular assist Device (BIVAD) or percutaneous LVAD
Device therapy (each yes/no)
Time frame: up to 12 months
Ejection fraction
Echocardiographic markers of function and rejection
Time frame: up to day 7
enddiastolic and endsystolic ventricle
Echocardiographic markers of function and rejection
Time frame: up to day 7
Cardiac arrhythmias
occurrence, severity, type
Time frame: up to day 7
Plan to share: No
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Dr. F. Köhler Chemie GmbH