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

Primary Purpose

Heart Failure

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Custodiol-N

Custodiol

organ perfusion for heart transplantation

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universitätsklinik für Chirurgie-Klin. Abteilung für Herzchirurgie, MUW-AKH Wien
Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW
Klinik für Herz-, Thorax- und Gefäßchirurgie, Deutsches Herzzentrum Berlin
Klinik für Kardiovaskuläre Chirurgie, Universitätsklinikum Düsseldorf
Klinik für Herz- und Gefäßchirurgie, Universitätszentrum Freiburg Bad Krotzingen
Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg
Abt. Herzchirugie, Universitätsklinikum Heidelberg
Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena
Herz- Thorax- und herznahe Gefäßchirurgie, Klinikum der Universität Regensburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Custodiol-N

Custodiol

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Catecholamine requirement

defined as "yes" or "no"

Patient survival

Complications

occurrence, severity, type, and duration

Full Information

NCT ID

NCT02869022

First Posted

August 11, 2015

Last Updated

January 14, 2020

Sponsor

Dr. F. Köhler Chemie GmbH

1. Study Identification

Unique Protocol Identification Number

NCT02869022

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

July 2016 (Actual)

Primary Completion Date

September 2, 2019 (Actual)

Study Completion Date

September 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dr. F. Köhler Chemie GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Custodiol-N

Arm Type

Experimental

Arm Description

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

Arm Title

Custodiol

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Custodiol-N

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Custodiol

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

organ perfusion for heart transplantation

Primary Outcome Measure Information:

Title

Creatine kinase Myocard type "CK-MB" peak value

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Catecholamine requirement

Description

defined as "yes" or "no"

Time Frame

from entry to the trial up to day 7

Title

Patient survival

Time Frame

at 7 days and 1, 3 and 12 months

Title

Complications

Description

occurrence, severity, type, and duration

Time Frame

from the time of the transplantation up to day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gabor Szabo, Prof. Dr.

Organizational Affiliation

Abt. Herzchirugie, Universitätsklinikum Heidelberg

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

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

City

Bad Oeynhausen

ZIP/Postal Code

32545

Country

Germany

Facility Name

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

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Klinik für Kardiovaskuläre Chirurgie, Universitätsklinikum Düsseldorf

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Klinik für Herz- und Gefäßchirurgie, Universitätszentrum Freiburg Bad Krotzingen

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Abt. Herzchirugie, Universitätsklinikum Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena

City

Jena

ZIP/Postal Code

07747

Country

Germany

Facility Name

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

City

Regensburg

ZIP/Postal Code

93042

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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