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Completed

NCT Number: NCT02869022

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Custodiol-N

Drug

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

Custodiol

Drug

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

organ perfusion for heart transplantation

Procedure

Primary outcomes

  1. Creatine kinase Myocard type "CK-MB" peak value

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

    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

Secondary outcomes

  1. Catecholamine requirement

    Time frame: from entry to the trial up to day 7

    defined as "yes" or "no"

  2. Patient survival

    Time frame: at 7 days and 1, 3 and 12 months

  3. Complications

    Time frame: from the time of the transplantation up to day 7

    occurrence, severity, type, and duration

Sponsors and collaborators

Lead sponsor

Dr. F. Köhler Chemie GmbH

Industry

Registry information

Official study title

A Prospective, Randomized, Single Blind, Multicenter Phase III Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2016
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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