Post Static Cold Storage Normothermic Machine Liver Perfusion

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

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-07-31

Brief Summary

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The aim of this study is to assess the safety and feasibility of a short period of cold storage prior to normothermic machine perfusion in adult liver transplantation.

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Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Normothermic Machine Liver Perfusion

Liver Preservation Method

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Donors over the age of 16 years.
* Liver allografts from donation after brain death (DBD), standard and extended criteria donors. (SCD, ECD) and donation after circulatory death (DCD) donors.
* Liver must be perfused on OrganOx metra perfusion device within 8 hours of in situ cold perfusion.
* The perfusion should last a minimum of 4 hours and maximum of 24 hours.

* Adult patients (18 years or more).
* Active on the waiting list for liver transplantation.
* Able to give informed consent.

Exclusion Criteria

* Living donors.
* Liver being transplanted as part of a multi-organ transplant (eg liver and kidney).
* Liver intended for split transplant.
* Donor age \<16 years
* Liver which investigator is unwilling to recruit to study.
* Any liver in which logistics prevent perfusion on the OrganOx metra perfusion device within 8 hours of in situ cold perfusion.

* Age less than 18 years.
* Acute/fulminant liver failure.
* Transplantation of more than one organ (e.g. liver and kidney).
* Refusal of informed consent.
* Unable to give informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No