NCT06032195

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
16mo left

Started Aug 2023

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Aug 2023Sep 2027

Study Start

First participant enrolled

August 15, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

August 21, 2023

Last Update Submit

January 28, 2026

Conditions

Heart Transplantation

Outcome Measures

Primary Outcomes (1)

  • adverse event reporting

    Safety assessment

    up to 3 months

Secondary Outcomes (23)

  • heart rate

    up to day 7 after release of the aortic cross clamp

  • blood pressure (systolic (SBP) and diastolic (DBP))

    up to day 7 after release of the aortic cross clamp

  • body temperature

    up to day 7 after release of the aortic cross clamp

  • concentration of cardiac troponin

    up to day 7 after release of the aortic cross clamp

  • concentration of creatinine kinase (CK-MB)

    up to day 7 after release of the aortic cross clamp

  • +18 more secondary outcomes

Study Arms (2)

Custodiol-N

EXPERIMENTAL

organ will be perfused with Custodiol-N solution

Drug: Custodiol-N

Custodiol

ACTIVE COMPARATOR

organ will be perfused with Custodiol solution

Drug: Custodiol

Interventions

Custodiol-NDRUG

heart will preserved in and will be treated with Custodiol-N solution

Also known as: Solution for organ preservation in transplantation
Custodiol-N
CustodiolDRUG

heart will preserved in and will be treated with Custodiol solution

Also known as: Solution for organ preservation in transplantation
Custodiol

Eligibility Criteria

Age24 Hours - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Deutsches Herzzentrum der Charité

Berlin, 13353, Germany

RECRUITING

Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie

Giessen, 35385, Germany

RECRUITING

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

München, 81377, Germany

RECRUITING

MeSH Terms

Interventions

Custodiol-N solutionSolutionsOrgan PreservationTransplantation

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTissue PreservationPreservation, BiologicalTherapeuticsInvestigative TechniquesSurgical Procedures, Operative

Study Officials

  • Christoph Knosalla, Prof. Dr.

    Deutsches Herzzentrum der Charité

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roman Petrov, Dr.

CONTACT

+ 49-6251-1083r.petrov@koehler-chemie.de

Kathleen Steyrer

CONTACT

+49-6221-56kathleen.steyrer@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patient and their legal representatives will be blinded to treatment. All other parties are unblinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

September 11, 2023

Study Start

August 15, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)