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

Phase 3

Completed

• Conditions: Heart Failure
• Interventions: Drug: Custodiol-N; Drug: Custodiol; Procedure: organ perfusion for heart transplantation

• Registration Number: NCT02869022
• Lead Sponsor: Dr. F. Köhler Chemie GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-11
• Study Start: 2016-07
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-16
• Primary Completion: 2019-09-02
• Study Completion: 2019-09-02
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Custodiol-N	Custodiol-N	comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
Custodiol-N	organ perfusion for heart transplantation	comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
Custodiol	Custodiol	comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
Custodiol	organ perfusion for heart transplantation	comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation

Primary Outcome Measures

Name	Time	Method
Creatine kinase Myocard type "CK-MB" peak value	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 Outcome Measures

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

Trial Locations

Locations (9)

Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Klinik für Kardiovaskuläre Chirurgie, Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Universitätsklinik für Chirurgie-Klin. Abteilung für Herzchirurgie, MUW-AKH Wien; 🇦🇹 Wien, Austria

Klinik für Herz-, Thorax- und Gefäßchirurgie, Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, 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, Germany