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

D

Dr. Franz Köhler Chemie

Status and phase

Completed
Phase 3

Conditions

Heart Failure

Treatments

Procedure: organ perfusion for heart transplantation
Drug: Custodiol
Drug: Custodiol-N

Study type

Interventional

Funder types

Industry

Identifiers

NCT02869022
CL-N-HTX-CSM-III/04/12
2012-001112-29 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

105 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

105 participants in 2 patient groups

Custodiol-N
Experimental group
Description:
comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
Treatment:
Procedure: organ perfusion for heart transplantation
Drug: Custodiol-N
Custodiol
Active Comparator group
Description:
comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
Treatment:
Procedure: organ perfusion for heart transplantation
Drug: Custodiol

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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