VITTAL Viability testing and transplantation of marginal livers
Research type
Research Study
Full title
An open label, non-randomised, prospective, single arm trial, using normothermic machine liver perfusion NMLP to test viability and transplantation of marginal livers
IRAS ID
206074
Contact name
Darius Mirza
Contact email
Sponsor organisation
University of Birmingham
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Liver transplantation is a highly successful form of treatment for many forms of end-stage liver disease. However, there is currently a shortage of livers for patients on the Liver Transplant Waiting List. This inevitably means that up to 20% of patients waiting for a liver transplant die or are removed from the list due to poor health, whilst waiting for a suitable organ. In order to respond to this shortage, clinicians are using organs that would previously not have been used for transplantation, for example from older donors or from non-heart beating donors.
This study uses a technique called a normothermic machine liver perfusion (NMLP), where the liver is placed onto a machine prior to transplantation. Oxygenated blood, medications and other fluids are circulated through the liver at 37C. We have identified criteria that we believe indicate whether a liver is functioning. In this study we will be using a NMLP machine called the OrganOx metra® to evaluate the function of livers that have been rejected for transplantation. If the liver meets these criteria the liver will be transplanted into a consented suitable recipient. This study is designed to demonstrate the potential of normothermic machine liver perfusion (NMLP) to not only increase the donor pool by transplanting livers which would have previously been rejected for clinical use, but also to improve patient safety by reducing or removing the likelihood of a liver failing to function after transplantation.REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1056
Date of REC Opinion
14 Jun 2016
REC opinion
Favourable Opinion