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New solution may keep donor hearts safer for kids

NCT ID NCT06032195

Disease control Sponsor: Dr. F. Köhler Chemie GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new liquid (Custodiol-N) used to preserve donor hearts before transplant in children. 15 children receiving their first heart transplant will be randomly assigned to get a heart stored in either the new or standard solution. The main goal is to check if the new solution is safe by tracking side effects and vital signs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

24 hours to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 guardians (must be available before enrolment in the study) * Patient listed on the waiting list for heart transplantation Exclusion Criteria: * 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 * Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities * Pregnancy and lactation

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Conditions

The condition(s) this trial relates to.

advanced heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart transplantation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Deutsches Herzzentrum der Charité

    RECRUITING

    Berlin, 13353, Germany

  • Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische Klinik

    RECRUITING

    München, 81377, Germany

  • Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie

    RECRUITING

    Giessen, 35385, Germany

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