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. 2019 Mar 15;2019(3):CD011671. doi: 10.1002/14651858.CD011671.pub2
Methods Multicenter, prospective, open, controlled and randomised trial comparing static incubation and pulsatile machine perfusion in expanded criteria donors
Participants Inclusion criteria for donors (ECD)
  • Donors aged > 60 years

  • Donors aged between 50 and 60 years of age with at least one of the following characteristics: history of diabetes mellitus; history of high blood pressure; SCr > 1.5 mg/dL; death by stroke (haemorrhagic or thrombotic)


Inclusion criteria for recipient
  • Registered on the kidney transplant waiting list likely to receive a marginal kidney

  • Immunized patients whose anti‐HLA antibody specificities have been determined


Exclusion criteria for recipient
  • Pregnant or breastfeeding women

  • People who have been incarcerated

  • Minors

  • Adults under guardianship

  • People who are not affiliated with the French healthcare system

  • People with HLA immunization whose HLA antibody specificities have not been determined

Interventions Static incubation
  • Kidneys in this group are conserved in University of Wisconsin (e.g., UW, Belzer® or Viaspan®), IGL‐1, or SCOT solution before being transplanted


Pulsatile perfusion
  • Kidneys in this group are placed in the pulsatile perfusion machine (RM 3) within two hours and should be kept there at least 6 hours and 8 hours if possible, before being transplanted

Outcomes
  • DGF

  • Evaluate improvement in the glomerular filtering rate: 12 months after transplantation

  • Evaluate the recourse to dialysis: 3 months following transplantation

  • Evaluate the proportion of functional grafts (which allows for renal purification without recourse to dialysis): 12 months after transplantation

  • Evaluate patient survival: 12 months after transplantation

  • Stratify the analysis of regaining function and graft survival using Nyberg's classification in order to determine which risk groups would most benefit from pulsatile perfusion: 12 months after transplantation

  • Identify perfusion profiles of the machine, which predict regaining kidney function (absence of dialysis during the week after transplantation) and graft survival: 12 months after transplantation

  • Evaluate the medico‐economic impact of each conservation strategy in the management of patients who will benefit from marginal grafts: 12 months after transplantation

Notes Study marked as complete (www.clinicaltrials.gov/ct2/show/study/NCT01170910) but no results available despite attempted contact with the authors.

DGF ‐ delayed graft function; ECD ‐ extended/expanded criteria donors; SCr ‐ serum creatinine