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

Sponsor
Dr. F. Köhler Chemie GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT02869022
Collaborator
(none)
105
Enrollment
9
Locations
2
Arms
38
Actual Duration (Months)
11.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Sep 2, 2019
Actual Study Completion Date :
Sep 2, 2019

Arms and Interventions

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

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

Procedure: organ perfusion for heart transplantation

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Catecholamine requirement [from entry to the trial up to day 7]

    defined as "yes" or "no"

  2. Patient survival [at 7 days and 1, 3 and 12 months]

  3. Complications [from the time of the transplantation up to day 7]

    occurrence, severity, type, and duration

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitätsklinik für Chirurgie-Klin. Abteilung für Herzchirurgie, MUW-AKH Wien Wien Austria 1090
2 Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW Bad Oeynhausen Germany 32545
3 Klinik für Herz-, Thorax- und Gefäßchirurgie, Deutsches Herzzentrum Berlin Berlin Germany 13353
4 Klinik für Kardiovaskuläre Chirurgie, Universitätsklinikum Düsseldorf Düsseldorf Germany 40225
5 Klinik für Herz- und Gefäßchirurgie, Universitätszentrum Freiburg Bad Krotzingen Freiburg Germany 79106
6 Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg Hamburg Germany 20246
7 Abt. Herzchirugie, Universitätsklinikum Heidelberg Heidelberg Germany 69120
8 Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena Jena Germany 07747
9 Herz- Thorax- und herznahe Gefäßchirurgie, Klinikum der Universität Regensburg Regensburg Germany 93042

Sponsors and Collaborators

  • Dr. F. Köhler Chemie GmbH

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. F. Köhler Chemie GmbH
ClinicalTrials.gov Identifier:
NCT02869022
Other Study ID Numbers:
  • CL-N-HTX-CSM-III/04/12
  • 2012-001112-29
First Posted:
Aug 16, 2016
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Jan 18, 2020