Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation

Last updated: January 14, 2020
Sponsor: Dr. F. Köhler Chemie GmbH
Overall Status: Completed

Phase

3

Condition

Congestive Heart Failure

Heart Failure

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT02869022
CL-N-HTX-CSM-III/04/12
2012-001112-29
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria: 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

Exclusion

Exclusion Criteria: 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

Study Design

Total Participants: 105
Study Start date:
July 01, 2016
Estimated Completion Date:
September 02, 2019

Connect with a study center

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

    Wien, 1090
    Austria

    Site Not Available

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

    Bad Oeynhausen, 32545
    Germany

    Site Not Available

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

    Berlin, 13353
    Germany

    Site Not Available

  • Klinik für Kardiovaskuläre Chirurgie, Universitätsklinikum Düsseldorf

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Klinik für Herz- und Gefäßchirurgie, Universitätszentrum Freiburg Bad Krotzingen

    Freiburg, 79106
    Germany

    Site Not Available

  • Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg

    Hamburg, 20246
    Germany

    Site Not Available

  • Abt. Herzchirugie, Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

  • Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena

    Jena, 07747
    Germany

    Site Not Available

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

    Regensburg, 93042
    Germany

    Site Not Available

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