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Research type
Research Study
Full title
A multicentre randomised controlled trial to compare the efficacy of ex-vivo oxygenated hypothermic machine perfusion with non-oxygenated hypothermic machine perfusion of kidneys older than 50 years of age and donated after circulatory death.
IRAS ID
153651
Contact name
Rutger Ploeg
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN32967929
Research summary
Kidney transplantation is the best treatment for end-stage renal disease. Because of the ongoing organ shortage, higher-risk kidneys are being transplanted more often, especially the use of kidneys donated after circulatory death (DCD) and from older donors (aged 50 years or more). These higher-risk kidneys are especially vulnerable to reperfusion injury (tissue damage when blood supply is returned after a period with no blood supply). The return of the blood supply can result in inflammation and cause problems with kidney function. It is therefore vital to preserve the kidney so that it is kept in optimal condition prior to transplantation to avoid delayed graft function and improve long term outcomes. The standard method of storing and transporting a kidney for transplantation is to perfuse it with a cold perfusion solution and store the kidney in sterile bags on melting ice in a box. However, it has already been shown that hypothermic machine perfusion preservation, where the cold preservation solution is continuously perfused through the kidney, improves short term graft function. Nevertheless, this preservation method still needs improvement to also increase long term graft function.
In this study, oxygenated hypothermic machine perfusion will be compared with non-oxygenated hypothermic machine perfusion. One kidney from all consecutive DCD Maastricht category III donors (donation after circulatory death) aged 50 years or older within the study region will be allocated to hypothermic machine perfusion (control group) and the other to hypothermic machine perfusion with oxygen (study group). Recipients will then undergo kidney transplantation and be managed according to standard local protocols. The two groups will be compared to investigate the potential benefit of the addition of oxygen during hypothermic machine perfusion preservation.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
14/SC/1056
Date of REC Opinion
25 Jul 2014
REC opinion
Further Information Favourable Opinion