ISRCTN63852508

Trial name or title	COPE‐POMP: ‘in house’ pre‐implantation oxygenated hypothermic machine perfusion reconditioning after cold storage versus cold storage alone in expanded criteria donor (ECD) kidneys from brain dead donors
Methods	Prospective parallel group RCT patient‐blinded controlled multicentre non‐paired superiority study
Participants	Kidneys donated after brain death from donors fulfilling the United Network for Organ Sharing (UNOS) ECD criteria. Participants are expected from Germany, Belgium, the Netherlands and UK
Interventions	ECD kidneys will be randomised to be preserved using either SCS alone or SCS followed by hypothermic oxygenated MP Group 1: the kidney will be retrieved and stored in cold storage solution until back‐table preparation and kidney transplantation are performed Group 2: the kidney will be placed in cold storage solution until arrival at the recipient's transplant centre. 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
Outcomes	Graft survival after 1 year Patient and graft survival at day 7, and at 3, 6 and 12 months after transplantation 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 DGF, defined as the need for dialysis within the first 7 days after transplantation and preceding the return of kidney function Slow graft function (SGF) based on functional DGF, defined as the absence of a decrease in the SCr level of at least 10% per day for at least 3 consecutive days in the first 7 days after transplantation PNF, defined as the continued need for dialysis at 3 months after transplantation Biopsy proven acute rejection incidence Quality of life measures (EQ‐5D‐5L) at time of consent, 3 and 12 months Health economic analysis: length of hospital stay, intensive care unit stay, requirement of dialysis Incidence of hyperkalaemia at 3, 6 and 12 months Incidence of calcineurin inhibitor toxicity
Starting date	01/12/2013
Contact information	Prof Andreas Paul Department of General Visceral and Transplant Surgery University Hospital Essen Hufelandstr. 55 Essen 45147 Germany
Notes	Study ongoing as of 15/12/2016, expected to finish 31/12/2018