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:
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| 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 Afterwards, steroids were withdrawn | |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 |