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

January 14, 2020 updated by: Dr. F. Köhler Chemie GmbH

A Prospective, Randomized, Single Blind, Multicenter Phase III 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Universitätsklinik für Chirurgie-Klin. Abteilung für Herzchirurgie, MUW-AKH Wien
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW
      • Berlin, Germany, 13353
        • Klinik für Herz-, Thorax- und Gefäßchirurgie, Deutsches Herzzentrum Berlin
      • Düsseldorf, Germany, 40225
        • Klinik für Kardiovaskuläre Chirurgie, Universitätsklinikum Düsseldorf
      • Freiburg, Germany, 79106
        • Klinik für Herz- und Gefäßchirurgie, Universitätszentrum Freiburg Bad Krotzingen
      • Hamburg, Germany, 20246
        • Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg
      • Heidelberg, Germany, 69120
        • Abt. Herzchirugie, Universitätsklinikum Heidelberg
      • Jena, Germany, 07747
        • Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena
      • Regensburg, Germany, 93042
        • Herz- Thorax- und herznahe Gefäßchirurgie, Klinikum der Universität Regensburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Custodiol-N
comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
Drug: Custodiol-N
comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation
Procedure: organ perfusion for heart transplantation
Active Comparator: Custodiol
comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
Procedure: organ perfusion for heart transplantation
Drug: Custodiol
comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from 4 to 168 hours after release of the aortic cross clamp

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catecholamine requirement
Time Frame: from entry to the trial up to day 7
defined as "yes" or "no"
from entry to the trial up to day 7
Patient survival
Time Frame: at 7 days and 1, 3 and 12 months
at 7 days and 1, 3 and 12 months
Complications
Time Frame: from the time of the transplantation up to day 7
occurrence, severity, type, and duration
from the time of the transplantation up to day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. F. Köhler Chemie GmbH

Investigators

  • Principal Investigator: Gabor Szabo, Prof. Dr., Abt. Herzchirugie, Universitätsklinikum Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

September 2, 2019

Study Completion (Actual)

September 2, 2019

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-N-HTX-CSM-III/04/12
  • 2012-001112-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Custodiol-N

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe