Post static cold storage normothermic machine liver perfusion
Research type
Research Study
Full title
A multicentre, single-arm, prospective clinical trial to investigate the safety and feasibility of cold storage prior to normothermic machine perfusion in adult human liver transplantation.
IRAS ID
213564
Contact name
Peter Friend
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Liver transplantation is the only successful treatment for end-stage liver disease but it is limited by a shortage of donor organs. In an attempt to tackle the organ deficit, an increasing number of marginal organs, which are significantly more susceptible to cold storage-related injury, are being transplanted with varying success.
The key to the successful transplantation of marginal livers may lie in the preservation method. Current practice involves static cold storage of an organ. However, novel technology known as normothermic machine perfusion (NMP) maintains the liver outside of the body on a machine, providing it with oxygen and nutrition at normal body temperature. The liver is therefore functional during the preservation period, producing bile, metabolising glucose and maintaining a physiological pH. This permits objective assessment of organ performance prior to transplantation, extended preservation times and there is evidence to suggest it can result in organ repair.
The University of Oxford have recently completed a phase III randomised controlled trial comparing NMP with static cold storage in liver transplantation. Preliminary data analysis demonstrates a statistically significant reduction in peak liver enzyme levels in the NMP group, a surrogate marker for long-term liver function. For this study, preservation NMP was undertaken. This means that the liver was placed on the circuit immediately following retrieval and was transported to the recipient hospital for transplantation. The proposed study aims to establish the safety and feasibility of post static cold storage NMP (pSCS-NMP) with the primary outcome of 30 day patient and graft survival. This practice would enable the liver to be transported on ice to the recipient hospital before being placed on the NMP circuit, deriving logistic and cost benefits. We also plan to compare outcomes between preservation NMP, pSCS-NMP and cold storage using matched controls.REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/2196
Date of REC Opinion
21 Dec 2016
REC opinion
Favourable Opinion