Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The OrganOx metra is an automated transportable device for preserving donated livers for transplantation. The aim of this study is to assess the safety and performance of the OrganOx Metra as an organ preservation method before liver transplantation.

Who can participate?
Patients aged 18 or older on the waiting list for liver transplantation

What does the study involve?
Participants receive liver transplants that have been preserved using the OrganOx metra device. The functioning of the transplanted liver and the patient survival rate are compared with the results from livers that were preserved using the conventional ice bucket method.

What are the possible benefits and risks of participating?
This study may demonstrate the safety and performance of the OrganOx metra as a medical device for the preservation of livers before transplantation. It is hoped that there will be benefits in terms of both the quality and quantity of livers available for transplantation. We believe that this would reduce the waiting time for liver transplantation and improve outcomes for patients. Liver transplant surgery carries a risk of significant complications, including bile duct complications, bleeding, blood clots, infection, memory and thinking problems, and failure or rejection of the donated liver. Using the OrganOx Metra does not increase the level of risk to the patient.

Where is the study run from?
Kings College Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2012 to December 2013

Who is funding the study?
OrganOx Ltd (UK)

Who is the main contact?
Dr Toni Day

Trial website

Contact information



Primary contact

Prof Nigel Heaton


Contact details

King's College Hospital
Institute of Liver Studies
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Non-randomised, open-label, single-arm, prospective clinical investigation to assess the safety and performance of the Organox Metra, for normothermic perfusion of livers, prior to transplantation and to compare with retrospective data from matched controls


Study hypothesis

To assess the safety and performance of normothermic perfusion as an organ preservation method prior to liver transplantation using the OrganOx Metra.

Ethics approval

Dulwich Research Ethics Committee, 19/07/2012

Study design

Non-randomised open-label single-arm prospective clinical investigation

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Liver transplant


Treatment arm 1: livers transplanted after preservation on the OrganOx metra device, the methodology for current clinical practice for liver transplantation is observed.

Treatment arm 2: Retrospectively collected data from livers transplanted after preservation using the conventional ice bucket, the methodology for current clinical practice for liver transplantation is observed.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Graft survival at 30 days

Secondary outcome measures

1. Histological post-reperfusion biopsies (H&E and immunohistochemistry) 60 minutes after arterial reperfusion (before abdominal closure)
2. Markers of endothelial damage and pro-inflammatory cytokines (TNF, IL-6, vWF) (postoperative)
3. Markers of liver function (Bilirubin, Alkaline phosphatase, GGT, AST, creatinine (postoperative)
4. Six month magnetic resonance cholangiopancreatography (MRCP) appearances
5. Six month graft survival
6. Six month patient survival

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Organ inclusion criteria
1. Livers from male or female adult donors (18 years or greater)
2. Accepted for transplantation using current (standard and extended) criteria
3. Both heart-beating (DBD) and non-heart-beating (DCD) donor organs may be included

Recipient Inclusion criteria
1. Male or female, aged 18 years or older
2. On the waiting list for liver transplantation at King’s College Hospital, London.
3. Provided informed consent for participation in the study
4. Able and willing to comply with all study requirements (in the opinion of the investigator or nominated deputy)

Participant type


Age group




Target number of participants


Participant exclusion criteria

Organ exclusion criteria
1. Livers offered from a donor hospital that is located more than 3 hours travelling time (by road) of both King’s College Hospital and Oxford.
2. Donors in whom the liver is planned to be split.
3. Donor livers that would not be accepted under current (King’s College Hospital) criteria.
4. Livers taken from donors aged <18 years.
5. Donors with high donor serum Na+ (> 160 mmol/litre) at the time of liver retrieval.

Recipient Exclusion criteria
The participant may not enter the study if ANY of the following apply:
1. Not willing to, unable or not capable to provide informed consent
2. Recipients aged less ˂18 years
3. Undergoing transplant for fulminant hepatic failure
4. Undergoing re-transplantation.
5. Undergoing transplantation of other organ(s) in addition to the liver
6. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk by participating in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
7. Not suitable for any other reason, in the opinion of the Investigator, to take part in the study.
8. Enrolled in clinical studies of other unlicensed therapy.
9. Participated in another research study involving an investigational product in the previous 12 weeks.
10. Pregnant or nursing mothers

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital
United Kingdom

Sponsor information


OrganOx Ltd (UK)

Sponsor details

c/o Dr Toni Day
Magdalen Centre
United Kingdom

Sponsor type




Funder type


Funder name

OrganOx Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/04/2016: Plain English summary added.