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

  • Duration of study: 26 July 2014 to 22 August 2014; 26 January 2015 to 28 March 2015

  • Duration of follow‐up: 1 year

Participants
  • Country: Brazil

  • Setting: multicentre

  • Donor characteristics

    • Mean age (range): 50 years (20 to 71)

    • Some donors were ECD, but information on exact numbers was not provided.

    • Sex (M/F): 46/34

    • Inclusion criteria: "We screened all adult brain dead deceased donors referred to a single OPO during the enrollment period. To be included in the study it was required the availability of the equipment and trained surgeons and sufficient time to recover the organs, considering the distance to travel at the time of referral. "

    • Exclusion criteria: "We excluded donors younger than 18 years, with unstable hemodynamic condition, and when combined transplants were anticipated."

  • Recipient characteristics

    • Inclusion criteria: not reported.

    • Exclusion criteria: not reported.

    • sex (M/F): MP group (45/35); SCS group (49/31)

    • Mean age ± SD (years): MP group (47.4 ± 15.6); SCS group (48.9 ± 12.3)

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


Static cold storage
  • SPS‐1 (Organ Recovery Systems) or Celsior preservation solution (Genzyme) based on surgeon preference.


Mean CIT
  • Mean time was long but did not differ significantly between the groups: 25.6 ± 6.6 hours in the SCS group and 25.1 ± 6.3 hours in the MP group

Outcomes
  • DGF

  • PNF

  • Duration of DGF

  • Duration of hospital stay

  • Incidence of acute rejection

  • One‐year graft survival

  • One‐year patient survival

  • Kidney function at days 7, 14, 21, 28 and 365

Notes
  • 160 kidneys from 80 donors. All were DBD donors

  • One kidney from each pair assigned to MP and the other to SCS. Kidneys were assessed to ensure that both kidneys were suitable for HMP/SCS before randomisation. If either kidney could not be included, the pair was excluded from the study

  • Due to various factors, including long CIT and relatively haemodynamically compromised donors, the incidence of DGF is relatively high in Brazil. This increased incidence improves the ability of the study to identify interventions which affect DGF incidence

  • Funding source: Organ Recovery Systems provided the Lifeport kidney transporter machine, preservation solutions, perfusion kits and training of the organ recovery team

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation using a web based program (www.randomization.com)
Allocation concealment (selection bias) Low risk Once a random sequence was generated using a web based program allocations were placed in opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes Low risk No blinding but this is unlikely to affect the outcome, especially as there was no difference in CIT between the groups
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 Clear reasons given for excluded pairs of kidneys. Primary outcome data reported for all 160 included participants. Only 2/160 were lost to follow up and were therefore not included in the graft/patient survival analysis
Selective reporting (reporting bias) Low risk Outcomes suitable, with adequate reporting
Other bias Low risk Kidneys were assessed to ensure that both kidneys were suitable for HMP/SCS before randomisation. This removes the potential bias associated with excluding kidneys only if a kidney with unusual vascular anatomy is randomised to HMP