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. 2019 Mar 15;2019(3):CD011671. doi: 10.1002/14651858.CD011671.pub2
Methods
  • Study design: parallel RCT

  • Duration of study: August 2006 to October 2007

  • Duration of follow‐up: 12 months

Participants
  • Country: UK

  • Setting: multicentre

  • Donor characteristics

    • Mean age ± SD: 45.6 ± 29.2 years

    • Number of DCD: 45 (90 kidneys)

    • Number of ECD: 16 (32 kidneys)

    • Sex (M/F): 29/16

    • Inclusion criteria: "All adult DCD donors at the five participating UK centers were eligible for the study although only controlled DCD donors, in whom further active treatment had been deemed futile and life‐supporting treatment withdrawn (Maastricht category 3), were entered."

    • Exclusion criteria: not reported

  • Recipient characteristics

    • inclusion criteria: aged ≥ 18 years or over, and had a negative crossmatch.

    • Exclusion criteria: previous nonrenal organ transplant

    • Sex (M/F): MP group (31/14); SCS group (33/12)

    • Mean age ± SD (years): MP group (50.3 ± 28.4); SCS group (48.6 ± 13.9)

Interventions Machine perfusion
  • LifePort transporter machines (Organ Recovery Systems) using KPS‐1 solution


Static cold storage
  • UW solution.


Mean CIT
  • Did not differ significantly between the groups: 14.3 hours in the SCS group and 13.9 hours in the MP group.

Outcomes
  • DGF

  • PNF

  • Creatinine

  • Incidence of biopsy proven acute rejection

  • Patient and graft survival

  • Other measures of graft function

Notes
  • One kidney from each pair assigned to MP and the other to SCS

  • A few of the kidneys only received MP at the recipient centre, but most also received it in transit. Relatively low rate of DGF overall, compared to DCDs in other studies, which could explain why this study was negative

  • Funding source: " The Research described was funded by a large unrestricted research grant from Novartis Pharmaceuticals UK and a smaller grant from Organ Recovery Systems."

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated random sequences were used
Allocation concealment (selection bias) Low risk Central allocation at duty office of NHS blood and transplant
Blinding of participants and personnel (performance bias) All outcomes Low risk No blinding, but there was a randomisation scheme to dictate which kidney would be transplanted first, therefore the MP kidney was not always left to suffer longer CIT as is the case in some other studies
Blinding of outcome assessment (detection bias) All outcomes Low risk No blinding, but outcome measurements are unlikely to be affected by the lack of blinding
Incomplete outcome data (attrition bias) All outcomes Low risk Full follow‐up data for all patients, using an intention to treat model
Selective reporting (reporting bias) Low risk Outcomes suitable, with adequate reporting
Other bias Low risk All kidneys were transplanted, the indices gained from the MP process were not used to decide whether a kidney was transplanted