Study of Organ Perfusion in Heart Transplantation in Children
ConditionHeart Transplantation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age24-17
SponsorDr. F. Köhler Chemie GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Custodiol-N
Drugheart will preserved in and will be treated with Custodiol-N solution
Custodiol
Drugheart will preserved in and will be treated with Custodiol solution
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Custodiol-NExperimental treatment 1 intervention
Group B: CustodiolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
adverse event reporting
Safety assessment
Time frame
up to 3 monthsSecondary outcomes
1
heart rate
vital parameters
Time frame
up to day 7 after release of the aortic cross clamp2
blood pressure (systolic (SBP) and diastolic (DBP))
vital parameters
Time frame
up to day 7 after release of the aortic cross clamp3
body temperature
vital parameters
Time frame
up to day 7 after release of the aortic cross clamp4
concentration of cardiac troponin
laboratory tests
Time frame
up to day 7 after release of the aortic cross clampSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov