Corresponding Author: Peri Husen, MD, Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Hufelandstr 55, 45122 Essen, Germany (firstname.lastname@example.org).
Accepted for Publication: January 19, 2021.
Published Online: April 21, 2021. doi:10.1001/jamasurg.2021.0949
Author Contributions: Drs Husen, Paul, and Ploeg had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Ploeg and Paul contributed equally.
Concept and design: Husen, Jochmans, Knight, Ablorsu, Pratschke, Mathe, Leuvenink, Minor, Ploeg.
Acquisition, analysis, or interpretation of data: Husen, Boffa, Jochmans, Krikke, Davies, Mazilescu, Brat, Knight, Wettstein, Cseprekal, Banga, Bellini, Szabo, Darius, Quiroga, Mourad, Pratschke, Papalois, Mathe, Pirenne, Ploeg, Paul.
Drafting of the manuscript: Husen, Davies, Mazilescu, Cseprekal, Ablorsu, Darius, Mathe, Leuvenink, Ploeg, Paul.
Critical revision of the manuscript for important intellectual content: Husen, Boffa, Jochmans, Krikke, Brat, Knight, Wettstein, Banga, Bellini, Szabo, Darius, Quiroga, Mourad, Pratschke, Papalois, Mathe, Minor, Pirenne, Ploeg, Paul.
Statistical analysis: Husen, Davies.
Obtained funding: Husen, Ploeg.
Administrative, technical, or material support: Husen, Boffa, Mazilescu, Brat, Knight, Wettstein, Cseprekal, Banga, Bellini, Szabo, Ablorsu, Darius, Quiroga, Mourad, Pratschke, Papalois, Mathe, Minor, Ploeg, Paul.
Supervision: Husen, Jochmans, Knight, Darius, Quiroga, Pratschke, Papalois, Mathe, Leuvenink, Ploeg, Paul.
Conflict of Interest Disclosures: Dr Husen reports grants from European Union 7th Framework Programme during the conduct of the study. Dr Boffa reports other support from Astellas Pharma outside the submitted work. Dr Jochmans reports grants from European Union 7th Framework Programme during the conduct of the study and other support from European Society for Organ Transplantation and European Association for the Study of the Liver outside the submitted work. Dr Knight reports personal fees from OrganOx for clinical trial design outside the submitted work. Dr Leuvenink reports grants from European Union 7th Framework Programme during the conduct of the study. Dr Minor reports grants from the European Union during the conduct of the study. No other disclosures were reported.
Funding/Support: The trial was funded by the European Union 7th Framework Programme (Theme Health.2012.1.4-1, grant agreement 305934). Perfusion devices and disposables were obtained from Organ Assist. MedAssist provided logistical support in terms of delivery and collection of devices, disposables, and samples.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Contributions: This trial was conducted by the members of the Consortium for Organ Preservation in Europe. We thank the European Commission for their funding through the Seventh Framework Programme. We also thank Timothy Boland (trial management); Ally Bradley (trial management); Virginia Chiocchia, MSc (statistical analysis); Katherine Corr (trial management) (Nuffield Department of Surgical Sciences, University of Oxford, UK); H. Sijbrand Hofker, MD (local trial coordination) (Department of Surgery, University Medical Center Groningen, the Netherlands); Undine Gerlach, MD (local trial coordination) (Department of Surgery, Charité, Berlin, Germany); Halil Karadag, MD (sample collection) (Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Germany); Martin Kuizenga (assistance in machine preservation) (OrganAssist, the Netherlands); Rajeev Kumar, PhD (database management); Margaux Laspeyres, MA (trial management) (Nuffield Department of Surgical Sciences, University of Oxford, UK); Sarah Mertens (data collection and local coordination) (Transplant Research Group, Laboratory of Abdominal Transplantation, Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium); Bhumika Patel (biobank management) (Nuffield Department of Surgical Sciences, University of Oxford, UK); and Marianne Thijssen-Grooten (logistics support) (MedAssist, the Netherlands) for their support. We are indebted to the members of the data monitoring committee: Christopher J. E. Watson, MD (chair) (University of Cambridge, UK); Josep M Grinyó, MD (University of Barcelona, Spain); Gabriel C Oniscu, MD (Royal Infirmary of Edinburgh, UK); and Susan Charman, BSc, Dip Ed, MSc (London, UK), as well as to all our patients, the donors and their families. These individuals were not compensated.
AJ , Jassem
W , Gray
DW , Fuggle
SV , Welsh
KI , Morris
PJ . Delayed graft function: risk factors and the relative effects of early function and acute rejection on long-term survival in cadaveric renal transplantation. Clin Transplant
. 1999;13(3):266-272. doi:10.1034/j.1399-0012.1999.130308.xPubMedGoogle ScholarCrossref
AO , Hanson
JA , Meier-Kriesche
et al. Survival in recipients of marginal cadaveric donor kidneys compared with other recipients and wait-listed transplant candidates. J Am Soc Nephrol
. 2001;12(3):589-597.PubMedGoogle ScholarCrossref
CG , Thorpe
KE , Russell
JD , Churchill
DN . Comparison of mortality risk for dialysis patients and cadaveric first renal transplant recipients in Ontario, Canada. J Am Soc Nephrol
. 2000;11(5):917-922.PubMedGoogle ScholarCrossref
RA , Ashby
VB , Milford
et al. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med
. 1999;341(23):1725-1730. doi:10.1056/NEJM199912023412303PubMedGoogle ScholarCrossref
A , Amrillaeva
V , Hoyer
et al. Reconditioning by end-ischemic hypothermic in-house machine perfusion: a promising strategy to improve outcome in expanded criteria donors kidney transplantation. Clin Transplant
. 2017;31(3). doi:10.1111/ctr.12904PubMedGoogle Scholar
A , Moers
C , Smits
et al. Machine perfusion versus static cold storage in expanded criteria donor kidney transplantation: 3-year follow-up data. Transpl Int
. 2013;26(6):E52-E53. doi:10.1111/tri.12094PubMedGoogle ScholarCrossref
P , Ding
Z , He
Y , Zhang
J , Wang
X , Yang
Z . Hypothermic machine perfusion versus static cold storage in deceased donor kidney transplantation: a systematic review and meta-analysis of randomized controlled trials. Artif Organs
. 2019;43(5):478-489. doi:10.1111/aor.13364PubMedGoogle ScholarCrossref
SJ , Figueiredo
RS , Moir
JA , Goodfellow
M , Talbot
D , Wilson
CH . Machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev
. 2019;3:CD011671. doi:10.1002/14651858.CD011671.pub2PubMedGoogle Scholar
A , Moers
C , Treckmann
et al. Machine perfusion versus cold storage for the preservation of kidneys from donors ≥ 65 years allocated in the Eurotransplant Senior Programme. Nephrol Dial Transplant
. 2012;27(12):4458-4463. doi:10.1093/ndt/gfs321PubMedGoogle ScholarCrossref
A , Efferz
P , Paul
A , Minor
T . One or 4 h of “in-house” reconditioning by machine perfusion after cold storage improve reperfusion parameters in porcine kidneys. Transpl Int
. 2014;27(11):1214-1219. doi:10.1111/tri.12393PubMedGoogle ScholarCrossref
SA , Mohamed
IH , Bagul
A , Nicholson
ML . Hypothermic machine perfusion after static cold storage does not improve the preservation condition in an experimental porcine kidney model. Br J Surg
. 2011;98(7):943-950. doi:10.1002/bjs.7481PubMedGoogle ScholarCrossref
I , Brat
A , Davies
et al; COMPARE Trial Collaboration and Consortium for Organ Preservation in Europe (COPE). Oxygenated versus standard cold perfusion preservation in kidney transplantation (COMPARE): a randomised, double-blind, paired, phase 3 trial. Lancet
. 2020;396(10263):1653-1662. doi:10.1016/S0140-6736(20)32411-9PubMedGoogle ScholarCrossref
I , Hofker
HS , Davies
L , Knight
S , Pirenne
J , Ploeg
RJ ; COPE and participating centres. Oxygenated hypothermic machine perfusion of kidneys donated after circulatory death: an international randomised controlled trial. Am J Transplant
. 2019;19(suppl 3).Google Scholar
T , Gianello
P , Vergauwen
et al. The effect on early renal function of various dynamic preservation strategies in a preclinical pig ischemia-reperfusion autotransplant model. Am J Transplant
. 2019;19(3):752-762. doi:10.1111/ajt.15100PubMedGoogle ScholarCrossref
T , Vergauwen
M , Smith
et al. Brief O2
uploading during continuous hypothermic machine perfusion is simple yet effective oxygenation method to improve initial kidney function in a porcine autotransplant model. Am J Transplant
. 2020;20(8):2030-2043. doi:10.1111/ajt.15800PubMedGoogle ScholarCrossref
T , von Horn
C , Gallinat
et al. First-in-man controlled rewarming and normothermic perfusion with cell-free solution of a kidney prior to transplantation. Am J Transplant
. 2020;20(4):1192-1195. doi:10.1111/ajt.15647PubMedGoogle ScholarCrossref