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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-09-02

Brief Summary

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

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Custodiol-N

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

Group Type EXPERIMENTAL

Custodiol-N

Intervention Type DRUG

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

organ perfusion for heart transplantation

Intervention Type PROCEDURE

Custodiol

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

Group Type ACTIVE_COMPARATOR

Custodiol

Intervention Type DRUG

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

organ perfusion for heart transplantation

Intervention Type PROCEDURE

Interventions

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Custodiol-N

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

Intervention Type DRUG

Custodiol

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

Intervention Type DRUG

organ perfusion for heart transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No