Woman and Man
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Extract
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? European Union Who is the main contact? Professor Andreas Paul
Inclusion criteria
- Machine perfusion preservation techniques for ECD kidneys