Trials

Liver trial: normothermic machine perfusion vs. cold storage in liver transplants

 

This is a randomised controlled trial comparing the current standard method for preserving a liver (in an ice box; SCS) with a new technique called normothermic machine perfusion (NMP). This technology has been developed by Prof Peter Friend and Prof Constantin Coussios at Oxford University and the device is produced by OrganOx Ltd. The technique involves perfusing a liver with oxygenated blood, nutrients and medications at normal body temperature to preserve the organ in a functioning, physiological state.

 

A total of 220 livers are randomised to SCS or NMP in seven transplant centres in the UK, Spain, Germany and Belgium. If randomised to SCS the liver are stored in an ice box and the retrieval and transplant will proceed in the conventional manner. If the organ is randomised to NMP then it is placed on the OrganOx machine from the time of retrieval, throughout its storage and transport, until it is eventually transplanted.

 

The primary outcome measure for the trial is the peak transaminase level (AST) within seven days post-transplant. Many secondary outcomes are being recorded including graft survival and function, MRCP evidence of iscaemic cholangiopathy and a health economic analysis.

 

On 9 March 2016, the 220th liver for our analysis has been transplanted at the Queen Elizabeth Hospital in Birmingham (UK) completing our recruitment target! The team will now ensure a complete set of follow-up data for each trial patient before starting data analysis. Check back in with us when our first results are available.

 

POMP trial: oxygenated hypothermic kidney re-conditioning after cold storage

 

The objective of this randomised controlled trial is to evaluate pre-implantation reconditioning of donor kidneys from extended criteria donors (ECD) using oxygenated machine perfusion following cold storage. This study is led by Professor Andreas Paul from the University Clinic Essen in Germany and includes transplant centres in Germany, the UK, Belgium and The Netherlands. The trial device is provided by Organ Assist Products B.V. and the Centre for Evidence in Transplantation has supported trial design and protocol development.

 

Once ECD donors are identified and randomisation is undertaken, both donor organs are placed in cold storage. However one will then be placed in the trial device - Kidney Assist machine - and will receive hypothermic oxygenated machine perfusion for a minimum of two hours prior to transplantation. The primary outcome measure in this project is death censored graft survival at one year, with secondary measures of delayed graft function in the first post operative week, graft function, primary non function and graft and patient survival at three months and one year. We are also recording the length of hospitalisation, and take biopsies for histology pre and post perfusion, plus biopsies of proven rejections.

COMPARE trial: oxygenated vs. non oxygenated hypothermic machine perfusion in kidney transplantation

 

This randomised controlled trial is designed to question whether oxygenated machine perfusion is superior to non-oxygenated machine perfusion in increasing the longevity and quality of older cardiac death donors (DCD) kidneys for transplant. The trial is led by Professor Jacques Pirenne and his team at the University Hospitals Leuven (BE) and includes transplant centres in Belgium, The Netherlands and the UK. The trial device is provided by Organ Assist Products B.V. and support has been given by the Centre for Evidence in Transplantation in designing the study and writing the trial protocol.

 

The protocol sees DCD kidneys at donor centres immediately after procurement being randomised to hypothermic machine perfusion, one with oxygen, and one without oxygen. The organs are then transplanted into a recipient adult in end-stage renal failure on the active waiting list for a kidney only transplant. The primary outcome measure for this trial is long-term graft survival and secondary measures include primary non function, serum creanine at one, three and 12 months, functional delayed graft function as well as graft and patient survival.

This project has received funding from the European Union's 7th Framework Programme for research, technological development and demonstration under grant agreement 305934.

COPE Consortium - 2017