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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869022
• Other study ID #: CL-N-HTX-CSM-III/04/12
• Secondary ID: 2012-001112-29
• Status: Completed
• Phase: Phase 3
• Start date: July 2016
• Est. completion date: September 2, 2019

Study information

• Verified date: January 2020
• Source: Dr. F. Köhler Chemie GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: September 2, 2019
• Est. primary completion date: September 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Procedure:
• organ perfusion for heart transplantation

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dr. F. Köhler Chemie GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

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