NCT02869022

Brief Summary

The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P25-P50 for phase_3 heart-failure

Timeline
Completed

Started Jul 2016

Geographic Reach
2 countries

9 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 11, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3.2 years

First QC Date

August 11, 2015

Last Update Submit

January 14, 2020

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Creatine kinase Myocard type "CK-MB" peak value

    day 1: measurements 4, 8, 12, 16, 20, 24 hours ± 30 min; day 2-3: measurements 8, 16 and 24 hours ± 2 hours; day 4-7 one time/day

    from 4 to 168 hours after release of the aortic cross clamp

Secondary Outcomes (3)

  • Catecholamine requirement

    from entry to the trial up to day 7

  • Patient survival

    at 7 days and 1, 3 and 12 months

  • Complications

    from the time of the transplantation up to day 7

Study Arms (2)

Custodiol-N

EXPERIMENTAL

comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation

Drug: Custodiol-NProcedure: organ perfusion for heart transplantation

Custodiol

ACTIVE COMPARATOR

comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation

Drug: CustodiolProcedure: organ perfusion for heart transplantation

Interventions

Custodiol-NDRUG

comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation

Custodiol-N
CustodiolDRUG

comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation

Custodiol
organ perfusion for heart transplantationPROCEDURE
CustodiolCustodiol-N

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Donor criteria:
  • deceased donors should fulfil the criteria for organ donation (SCD) Patient criteria
  • recipients awaiting their first transplant
  • recipients ≥ 18 and \>/= 65 years
  • recipient's signed informed consent
  • waiting list

You may not qualify if:

  • Donor criteria:
  • not applicable
  • Patient criteria:
  • recipients participating in another interventional study
  • pregnant or lactating patients
  • history/demonstration of HIV antibodies or AIDS
  • multiorgan transplantation
  • transMedics pump
  • the explantation team is affiliated another clinic than transplantation team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Universitätsklinik für Chirurgie-Klin. Abteilung für Herzchirurgie, MUW-AKH Wien

Vienna, 1090, Austria

Location

Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Klinik für Herz-, Thorax- und Gefäßchirurgie, Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Klinik für Kardiovaskuläre Chirurgie, Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Klinik für Herz- und Gefäßchirurgie, Universitätszentrum Freiburg Bad Krotzingen

Freiburg im Breisgau, 79106, Germany

Location

Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg

Hamburg, 20246, Germany

Location

Abt. Herzchirugie, Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena

Jena, 07747, Germany

Location

Herz- Thorax- und herznahe Gefäßchirurgie, Klinikum der Universität Regensburg

Regensburg, 93042, Germany

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Custodiol-N solutionHeart Transplantation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical ProceduresOrgan TransplantationTransplantation

Study Officials

  • Gabor Szabo, Prof. Dr.

    Abt. Herzchirugie, Universitätsklinikum Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

August 16, 2016

Study Start

July 1, 2016

Primary Completion

September 2, 2019

Study Completion

September 2, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

DE(8)AU(1)