RCT of Normothermic Perfusion Vs Cold Storage in Liver Transplant v1
Research type
Research Study
Full title
A Multicentre Randomised Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion with Static Cold Storage in Human Liver Transplantation
IRAS ID
144811
Contact name
Peter Friend
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
There is currently a nationwide shortage of livers available for transplantation. This study is a multi-centre randomised controlled trial to assess the potential benefit of a novel method for storing a liver after it has been removed from the donor until it is transplanted. Adult patients with capacity on the liver transplant waiting list in participating centres will be asked if they wish to take part in this study. If they consent, then the organ they receive will be randomised to either conventional storage in an ice-box, or using the new method described below.
After removal from the donor, the liver is placed on the OrganOx metra machine which will perfuse it with nutrients and blood at normal body temperature until transplantation. Whilst on the machine it is possible to monitor the organ's function using multiple perfusion dynamic and biochemical parameters or by direct visual and manual inspection. The organ will remain on the machine until transplantation. At this point it is removed from the device and transplanted in the conventional manner.
There is accumulating evidence from lab studies and transplants in pigs that organs transplanted after being stored in this way have improved outcomes. A Phase I clinical trial involving 20 liver transplants has just completed recruitment and is providing evidence of safety.
The main outcome we are measuring is the level of liver enzymes in the first week after transplantation. Previous studies have shown a relationship between these enzymes and the likelihood of a transplant succeeding. We will also evaluate important early clinical and biochemical outcomes, organ and patient survival and changes in quality of life for the first 6 months after transplantation, at which point we will report our findings. Longer-term follow up of organ function and survival will continue for 2 years.
REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/0182
Date of REC Opinion
11 Apr 2014
REC opinion
Further Information Favourable Opinion