Currently submitted to: JMIR Research Protocols
Date Submitted: May 9, 2019
Open Peer Review Period: May 13, 2019 - May 27, 2019
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Hypothermic oxygenated machine perfusion of extended criteria kidney allografts from brain dead donors – a prospective cohort study
Background: Kidney transplantation is the only curative treatment option for end-stage renal disease. The unavailability of adequate organs for transplantation resulted in substantial organ shortage. As such, kidney donor allografts that would have previously been deemed unsuitable for transplantation, have become an essential organ pool of extended criteria donor allografts that are now routinely being transplanted on a global scale. These extended criteria donor allografts, however, are associated with significant graft related complications. As a result, hypothermic oxygenated machine perfusion has emerged as a powerful, novel technique in organ preservation, which has recently been tested in preclinical trials in kidney transplantation. In addition, hypothermic oxygenated machine perfusion has already provided promising results in few clinical series of liver transplantation in donation after cardiac death. Methods: The present trial is an investigator-initiated prospective cohort study on the effects of hypothermic oxygenated machine perfusion on extended criteria donor allografts in donation after brain death kidney transplantation. Fifteen kidney allografts with defined inclusion/exclusion criteria will be submitted to 2 hours of hypothermic oxygenated machine perfusion via the renal artery before implantation and are going to be compared to a case matched group of 30 patients (1:2 matching) transplanted after conventional cold storage. Primary (post-transplant dialysis within 7 days) and secondary (post-operative complications, early graft function, duration of hospital and intensive care unit stay, and six-month graft survival) endpoints will be analysed within a 6-month follow up. The extent of ischemia-reperfusion injury will be assessed using kidney tissue, perfusate, and serum samples taken during the perioperative phase of kidney transplantation. Discussion: The aim of this prospective cohort study is to investigate the effects of hypothermic oxygenated machine perfusion on extended criteria donor kidney allografts in donation after brain death. In times of organ shortage, it is of crucial interest to investigate systems of organ preservation that hold promise to better utilize marginal donor allografts. The present report represents the pre-results phase. First results are expected in Q3 2019. Trial registration number: NCT03378817 (clinicaltrials.gov) Keywords: Hypothermic oxygenated machine perfusion (HOPE), Donation after Brain Death (DBD), Extended Criteria Donor (ECD), Kidney Transplantation
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