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

  • Duration of study: not reported

  • Duration of follow‐up: 1 month

Participants
  • Country: Japan

  • Setting: single centre

  • Donor characteristics

    • Mean age: 51.1 years

    • Number of DCD donors: 13

    • Donor sex (M/F): not reported

    • Inclusion criteria: DCD donors

    • Exclusion criteria: not reported

  • Recipient characteristics

    • Inclusion criteria: not reported

    • Exclusion criteria: not reported

    • Sex (M/F): not reported

    • Mean age ± SD (years): MP group (41 ± 7.9); SCS group (38.5 ± 10.1)

Interventions Machine perfusion
  • APS‐02 (Nikiso) machine using cryoprecipitated plasma


Static cold storage
  • UW or Euro‐Collins solution


Mean CIT
  • Significantly different between the groups; 6.08 ± 2.93 hours in the SCS and 11.9 ± 3.20 hours in HMP (P < 0.05)

Outcomes
  • DGF: requirement for dialysis during the first week; labelled as post‐transplant ATN by the study

  • Requirement for dialysis at 2 weeks

  • Duration of dialysis

  • One month graft survival

Notes
  • 26 kidneys from 13 donors

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

  • There was a significantly longer CIT in the MP arm, suggesting that people were happy to leave perfused organs for longer

  • The rate of DGF found by this study was very high, which could explain how the study achieved statistical significance even with such a small sample size

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The study does not specify how, or at what time, the randomisation takes place. It only actually mentions that the study is randomised in the concluding paragraph
Allocation concealment (selection bias) Unclear risk The study does not specify how, or at what time, the randomisation takes place. It only actually mentions that the study is randomised in the concluding paragraph
Blinding of participants and personnel (performance bias) All outcomes High risk No blinding and there was a significant difference in CIT, suggesting that the groups were treated differently. Prolonged CIT is likely to affect the primary outcome of DGF
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 Data available for all included donors
Selective reporting (reporting bias) Low risk The outcomes reported were appropriate and expected
Other bias High risk The study does not state the duration of the study, whether they are consecutive cases, or how inclusion/randomisation took place