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Currently accepted at: JMIR Research Protocols

Date Submitted: May 9, 2019
Open Peer Review Period: May 13, 2019 - May 27, 2019
Date Accepted: Aug 30, 2019
(closed for review but you can still tweet)

This paper has been accepted and is currently in production.

It will appear shortly on 10.2196/14622

The final accepted version (not copyedited yet) is in this tab.

Hypothermic oxygenated machine perfusion of extended criteria kidney allografts from brain dead donors – protocol for a prospective cohort study

  • Franziska Alexandra Meister; 
  • Zoltan Czigany; 
  • Jan Bednarsch; 
  • Jörg Böcker; 
  • Iakovos Amygdalos; 
  • Daniel Antonio Morales Santana; 
  • Katharina Rietzler; 
  • Marcus Moeller; 
  • Rene Tolba; 
  • Peter Boor; 
  • Wilko Rohlfs; 
  • Ulf Peter Neumann; 
  • Georg Lurje

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.

Objective:

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.

Methods:

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.

Results:

Results of this trail are expected in Q3 2019 and will be presented at national and international scientific meetings and published in international peer-reviewed medical journals.

Conclusions:

This prospective cohort study is designed to explore the effects of hypothermic oxygenated machine perfusion on extended criteria donor kidney allografts in donation after brain death. The present report represents the pre-results phase.

ClinicalTrial:

NCT03378817 (clinicaltrials.gov)


 Citation

Please cite as:

Meister FA, Czigany Z, Bednarsch J, Böcker J, Amygdalos I, Morales Santana DA, Rietzler K, Moeller M, Tolba R, Boor P, Rohlfs W, Neumann UP, Lurje G

Hypothermic oxygenated machine perfusion of extended criteria kidney allografts from brain dead donors – protocol for a prospective cohort study

JMIR Research Protocols. (forthcoming/in press)

DOI: 10.2196/preprints.14622

URL: https://preprints.jmir.org/preprint/14622


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