Plain English Summary
Background and study aims
Kidney transplantation is a successful treatment for end-stage renal disease. The standard methods for storing and transporting kidneys for transplantation are to either store them in cold storage solution or to perfuse them with a cold perfusion solution on ice. It has been shown that machine perfusion preservation improves short term graft function, especially in kidneys donated by expanded criteria donors (ECD). Experimental models have shown that it is sufficient to perform machine perfusion immediately prior to implantation and reperfusion of the organ. This would also show a benefit to logistics, as kidneys would only need to be perfused at the transplantation center of the recipient. The aim of this study is to assess whether machine perfusion only immediately prior to implantation and after transport in cold storage solution will reduce damage, decrease ischemia-reperfusion injury and improve graft survival and function in ECD kidneys.
Who can participate?
Kidneys donated after brain death from donors fulfilling the United Network for Organ Sharing (UNOS) ECD criteria.
What does the study involve?
Two groups will be compared: a control group (static cold storage) and an interventional group (hypothermic oxygenated machine perfusion after static cold storage).
What are the possible benefits and risks of participating?
Short-term hypothermic oxygenated machine perfusion may be beneficial to static cold storage in ECD kidneys. In this study, two standard preservation methods are being compared.
Where is the study run from?
The trial will be carried out in academic hospitals with an active adult kidney transplant programme in Germany, Belgium, the Netherlands, United Kingdom and their donor hospitals. The lead center will be the University Hospital Essen, Germany.
When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in May 2014. Participants will be enrolled and followed-up in the study for a period of one year.
Who is funding the study?
Who is the main contact?
Professor Andreas Paul
A prospective, randomized, parallel group, single blinded, controlled, multi-center, non-paired superiority trial to compare the effect of short-term 'in house' oxygenated hypothermic machine perfusion preservation after static cold storage to static cold storage alone in transplantation of expanded criteria donor (ECD) kidneys donated after brain death
COPE-POMP (Consortium for Organ Preservation in Europe - Pre-implantation Oxygenated hypothermic Machine Perfusion)
Short-term reconditioning using hypothermic oxygenated machine perfusion preservation following static cold storage and prior to reimplantation is superior to static cold storage alone in ECD kidneys.
Ethics Board of the Faculty of Medicine, University of Duisburg-Essen, 25/09/2014, ref: 14-5783-BO
Prospective randomized parallel group patient-blinded controlled multi-center non-paired superiority trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Machine perfusion preservation techniques for ECD kidneys
ECD kidneys will be randomized to be preserved using either static cold storage alone or static cold storage followed by hypothermic oxygenated machine perfusion.
Group 1 - control group: the kidney wil be retrieved and stored in cold storage solution until back-table preparation and kidney transplantation are performed.
Group 2 - experimental group: the kidney will be placed in cold storage solution until arrival at the recipient's transplant center. Following back-table preparation the kidney will be placed on the Kidney Assist device to be perfused with cold oxygenated Belzer's Machine preservation solution until immediately before implantation.
The previous sponsor for this trial (up to 24/04/2014) was:
University Hospital Essen (Germany)
Primary outcome measures
Graft survival after 1 year
Secondary outcome measures
1. Patient and graft survival at day 7, and at 3, 6 and 12 months after transplantation
2. Estimated glomerular filtration rate (eGFR) defined by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation at days 7 and 14 and 3, 6 and 12 months after transplantation
3. Delayed graft function (DGF), defined as the need for dialysis within the first 7 days after transplantation and preceding the return of kidney function
4. Slow graft function (SGF) based on functional DGF (fDGF), defined as the absence of a decrease in the serum creatinine level of at least 10% per day for at least 3 consecutive days in the first 7 days after transplantation
5. Primary non-function (PNF), defined as the continued need for dialysis at 3 months after transplantation
6. Biopsy proven acute rejection incidence
7. Quality of life measures (EQ-5D-5L) at time of consent, 3 and 12 months
8. Health economic analysis: length of hospital stay, intensive care unit stay, requirement of dialysis
9. Incidence of hyperkalemia at 3, 6 and 12 months
10. Incidence of calcineurin inhibitor toxicity
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Kidneys from brain dead donors fulfilling the United Network for Organ Sharing ECD criteria
1. At least 18 years old.
2. Listed for renal transplantation due to end stage renal disease within one of the participating centers
3. The transplantation is the participant's first or re-transplantation
Target number of participants
Participant exclusion criteria
1. Kidney used for a multi-organ transplantation
2. Donor aged 85 or older
3. Donation after cardiac death
4. Kidney used for double-kidney transplantation within the same recipient
1. Simultaneous participation in another perfusion trial
2. Scheduled to undergo multi-organ transplantation
3. Planned dual-kidney transplantation
4. Both kidneys being transplanted within the same recipient
5. Is unable or unwilling to provide informed consent
Recruitment start date
Recruitment end date
Countries of recruitment
Belgium, Germany, Netherlands, United Kingdom
Trial participating centre
Department of General, Visceral and Transplant Surgery
University Hospital Essen
University of Oxford (UK)
c/o Ms Heather House
Joint Research Office
European Union - Seventh Framework Programme (FP7) (grant number 305934 - Work Package 3)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting