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. 2020 Jan 16;2020(1):CD013203. doi: 10.1002/14651858.CD013203.pub2

Llado 2006.

Methods Randomised clinical trial
Participants Country: Spain
Period of recruitment: 2001‐2004
Number randomised: 200
Post‐randomisation dropouts: 2 (1.0%)
Revised sample size: 198
Reasons for post‐randomisation dropouts: protocol violations
Average age (years): 54
Females: 43 (21.7%)
Primary transplantation: 198 (100.0%)
Reason for transplantation
Alcohol‐related cirrhosis: 55 (27.8%)
Viral‐related cirrhosis: 60 (30.3%)
Autoimmune disease‐related cirrhosis: 0 (0.0%)
HCC: 63 (31.8%)
Others: 20 (10.1%)
Maintenance immunosuppression used during induction immunosuppression: cyclosporin A plus mycophenolate mofetil
Altered immunosuppression after withdrawal: no
Other exclusion criteria:
  • transplant for fulminant liver disease

  • multiorgan transplant

  • HIV infection

Interventions Group 1: basiliximab (n = 96)
 Further details: basiliximab as two 20 mg doses: the first dose was administered within 6 hours of reperfusion (day 0), and the second dose on day 4 after transplantation
 Group 2: basiliximab + glucocorticosteroids (n = 102)
 Further details: basiliximab as two 20 mg doses: the first dose was administered within 6 hours of reperfusion (day 0), and the second dose on day 4 after transplantation + methylprednisolone (500 mg) as a single intravenous bolus before reperfusion; and afterwards, 0.5 mg/kg/day methylprednisolone until day 5, 0.25 mg/kg/day from day 5 to day 30, and 0.15 mg/kg/day from day 30 to day 90. Afterwards, steroids were withdrawn
Outcomes Outcomes reported: mortality at maximal follow‐up, graft rejection (any)
 Follow‐up (months): 6
Notes Source of funding (quote): "they received funding from the drug companies involved to carry out their research"
 Trial name/trial registry number: not stated
 Attempts were made to contact the authors in August 2019.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: this information was not available
Allocation concealment (selection bias) Low risk Quote: "eligible patients were randomized at the beginning of surgery, using sealed envelopes"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "an open‐label, not‐blinded"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "an open‐label, not‐blinded"
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: there were post‐randomisation dropouts. It was not clear whether these could be related to the interventions
Selective reporting (reporting bias) Low risk Comment: no pre‐published protocol was available, but the authors reported on mortality, graft loss, and adverse events
Other bias Low risk Comment: no other bias noted