Study of Organ Perfusion in Heart Transplantation in Children
Recruiting
Phase 2
Interventional Study
Heart Transplantation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 24 Hours – 17
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 15 (estimated)
- Sponsor
- Dr. F. Köhler Chemie GmbH · Industry
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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…
Trial Locations
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Eligibility Criteria
Inclusion 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 gua…
Contacts