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
| ISRCTN | ISRCTN14355416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14355416 |
| Secondary identifying numbers | ORG/NPL/001 |
- Submission date
- 11/10/2012
- Registration date
- 27/11/2012
- Last edited
- 25/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Contact information
Scientific
King's College Hospital
Institute of Liver Studies
London
SE5 9RS
United Kingdom
Study information
| Study design | Non-randomised open-label single-arm prospective clinical investigation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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(s) | Dulwich Research Ethics Committee, 19/07/2012 |
| 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 |
| Primary outcome measure | 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 study start date | 11/10/2012 |
| Overall study end date | 01/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| 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 Kings 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 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 Kings 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 (Kings 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 participants 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
- England
- United Kingdom
Study participating centre
SE5 9RS
United Kingdom
Sponsor information
Industry
c/o Dr Toni Day
Magdalen Centre
Oxford
OX5 1TN
United Kingdom
| Website | http://www.organox.com |
|---|---|
"ROR" |
https://ror.org/04fqe7a64 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2016 | Yes | No |
Editorial Notes
25/05/2018: Publication reference added.
06/04/2016: Plain English summary added.
