Condition category
Surgery
Date applied
11/10/2012
Date assigned
27/11/2012
Last edited
06/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
toni.day@organox.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nigel Heaton

ORCID ID

Contact details

King's College Hospital
Institute of Liver Studies
London
SE5 9RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ORG/NPL/001

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

Acronym

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

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Liver transplant

Intervention

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

Procedure/Surgery

Phase

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

11/10/2012

Overall trial end date

01/12/2013

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

20

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

11/10/2012

Recruitment end date

01/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

OrganOx Ltd (UK)

Sponsor details

c/o Dr Toni Day
Magdalen Centre
Oxford
OX5 1TN
United Kingdom

Sponsor type

Industry

Website

http://www.organox.com

Funders

Funder type

Industry

Funder name

OrganOx Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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.