OPE

Consortium for Organ Preservation in Europe

The COPE Consortium aims to advance and develop organ preservation technologies by performing clinical and translational studies with on-going experimental refinement. Through testing the quality and safety, increasing the efficiency and refining preservation strategies we aim to bring technologies from the bench to the bedside with direct impact for patients.

The Clinical Question

?

More complex solutions

In situnormothermic machine perfusion (NMP)

In situ normothermicregional perfusion (NRP)

Hypothermic machine perfusion (HMP) with oxygen

Hypothermic machine perfusion (HMP)

Static Cold Storage (SCS)

Our Research

Experimental research programmes on liver and kidney preservation

LIVERRCT

NMP

POMPRCT

SCSSCS

COMPARERCT

HMP

BIOBANK

O2

SCS

DCD>50 years kidneys

ECDkidneys

SCD & ECD

livers

O2HMP

O2HMP

Our BackgroundThe COPE Consortium is the official organ preservation task force of the European Society for Organ Transplantation and is funded through the EU’s 7th Framework Programme for research, technological development and demonstration. The consortium is led by Professor Rutger Ploeg at the University of Oxford and brings together academic institutions, clinical and scientific experts as well as small and medium sized enterprises from across Europe to work together on advancing organ preservation techniques.Focusing on three clinical trials, two experimental work programmes and the establishment of a bio-bank, the consortium will be working on improving preservation and reconditioning strategies for kidneys and livers retrieved for transplantation. By forming collaborations between industry and academic institutions we aim to introduce organ preservation technologies that will increase the number and quality of grafts used for transplantation.

LIVER RCTThe multinational randomised controlled liver trial compares the differences in preserving the liver prior to transplantation using normothermic machine perfusion vs. static cold storage. The trial is led by Professor Peter Friend at the University of Oxford, and includes four transplant centres in the UK (Birmingham, Cambridge, King’s College and Royal Free Hospital) as well as Essen in Germany, Leuven in Belgium and Barcelona in Spain. A total of 260 livers from SCD and ECD donors will be included in the trial and randomised to either normothermic machine perfusion, using the OrganOx metra device, or to static cold storage for the duration of their preservation.The primary outcome measure is the peak serum transaminase level (AST/ALT) within seven days post-transplant, and secondary measures include graft survival and function, MRCP evidence of ischaemic cholangiopathy, histological evidence of ischaemia-reperfusion injury as well as health economic analysis up to one year following transplantation.

POMP RCTThe goal of this randomised, controlled, multi-centre, superiority trial is to compare the effect of short-term oxygenated hypothermic machine perfusion after static cold storage to static cold storage alone in transplantation of ECD kidneys donated after brain death.The study is led by Professor Andreas Paul at the Department of Transplant Surgery at the University Hospital Essen (Germany) in collaboration with three European Transplant Centres, including Groningen (Netherlands), Leuven (Belgium) and Oxford (UK) with a total number of 262 kidneys to be included across all sites. Kidney Assist, the perfusion machine used for pre-implantation reconditioning is provided by the project partner Organ Assist BV.The primary outcome measure of this trial is graft survival at one year following transplantation. Secondary measures include delayed graft function, slow graft function, primary non-function, biochemical evaluation of kidney function, rejection periods, as well as health economic analysis up to one year following transplantation.

COMPARE RCTThis trial is designed to investigate whether oxygenated hypothermic machine perfusion is superior to non-oxygenated hypothermic machine perfusion in improving the function of older DCD kidneys for transplant. The trial is led by Professor Jacques Pirenne and his team in Leuven (Belgium) and includes all Belgian transplant centres, Groningen in The Netherlands with all Dutch transplant centres as well as Oxford in the UK with a large number of experienced British transplant centres.The study will include a total of 110 kidney pairs that will be randomised to hypothermic machine perfusion, one with oxygen, and one without. The primary outcome measure for this trial is one year kidney function with the secondary measures including delayed graft function, primary non function, graft and patient survival as well as health economic analysis up to one year following transplantation.

OPE

cope@nds.ox.ac.uk +44 (0) 1865 226100 www.cope-eu.org

PartnersThe COPE Consortium is the official organ preservation task force of the European Society for Organ Transplantation (ESOT). The Consortium brings together academic institutions, clinical and scientific experts and SMEs from across Europe.

University of Oxford University Medical Centre Groningen University of Duisburg-Essen University Clinic Bonn Université Pierre et Marie Curie, Paris VI Poitiers University, INSERM U1082 University of Leuven OrganOx Ltd. Organ Assist Products B.V. Aqix Ltd. HEMARINA S.A. European Society for Organ Transplantation Med-Assist B.V. Fundacio Clinic per a la Recerca Biomedica

Nuffield Department of Surgical SciencesOxford Transplant Centre, Churchill Hospital

This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 305934

Oxford

Paris

Poitiers

Leuven EssenBonn

Groningen

Barcelona

Bio-BankTo investigate the primary and secondary measures of our trials and to ensure future research, perfusate, blood, urine, bile and tissue samples will be collected during each donor and recipient transplant procedure to be stored in the COPE bio-bank in Oxford (UK). Lead by Professor Rutger Ploeg at the University of Oxford, the COPE bio-bank will create the foundation for future investigative possibilities. Within COPE, Prof Ploeg and his team will focus on identifying novel biomarkers through a variety of -omics studies including proteomics and metabolomics that will help predict organ quality and ultimately graft function and survival after transplantation.

Experimental WorkThe consortium also focuses on novel approaches in organ preservation using large models to test the quality of donor livers and kidney in the context of transplantation. The experimental work is led by Professor Henri Leuvenink at the University of Groningen in the Netherlands and by Professor Thomas Minor at the University of Bonn in Germany and also involves partners from Poitiers and Paris in France.

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