Background
Simple cold storage (CS) has been the preferred method of organ preservation for most transplant centers in Europe. Major transplant centers in the US have indicated that continuous hypothermic machine perfusion (MP) has definite advantages over CS with reduced percentages of delayed graft function (DGF) after kidney transplantation. Nevertheless, in most european centers, predominantly due to logistics and the perception of increased costs, MP has not been utilized or properly evaluated. Therefore no decision has been made as to the standard of care for organ preservation in particular how the preservation method (CS or MP) will affect outcome after transplantation. This study proposes a prospective randomized trial within an international organ sharing system to evaluate early graft function after MP preservation versus CS preservation.
Aim of Study
Does MP with UW-MP (Kidney Preservation Solution: KPS-1) improve early graft function in cadaveric renal transplantation in comparison to UW-CS (Viaspan®)? Assuming the 0-hypothesis that MP and CS give equal early graft function, the alternative hypothesis is that early graft function improves with MP.
Study Design
A prospective randomized controlled multicenter trial of paired kidneys from human cadaveric donors.
Study population
All potential consecutive cadaveric kidney donors >15 years from the collaborating donor regions (Belgium, The Netherlands and Nordrhein-Westfalen in Germany) reported to the ET desk are eligible for randomization. Follow up will be directed at all recipients of these kidney grafts.
Intervention
Machine Perfusion. After accepting the potential organ donor for actual donation, one of the kidneys is randomized to preservation by MP with the contralateral organ serving as a control being preserved by CS (Eurotransplant desk has randomization scheme).
Endpoint
Primary endpoint is DGF, defined as any dialysis requirement within 7 days post transplant.