Neumann 2012.
| Methods | Randomised clinical trial | |
| Participants | Country: multicentric (Europe)
Period of recruitment: 2005‐2008
Number randomised: 138
Post‐randomisation dropouts: 3 (2.2%)
Revised sample size: 135
Reasons for post‐randomisation dropouts: not transplanted or no study medication
Average age (years): 54
Females: 41 (30.4%)
Primary transplantation: 135 (100.0%)
Reason for transplantation Alcohol‐related cirrhosis: 0 (0.0%) Viral‐related cirrhosis: 135 (100.0%) Autoimmune disease‐related cirrhosis: 0 (0.0%) HCC: 0 (0.0%) Others: 0 (0.0%) Maintenance immunosuppression used during induction immunosuppression: tacrolimus Altered immunosuppression after withdrawal: no |
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| Interventions | Group 1: daclizumab (n = 67) Further details: daclizumab 2 mg/kg two doses: the first dose was given during the anhepatic period and the second dose between days 7 and 10 Group 2: glucocorticosteroids (n = 68) Further details: glucocorticosteroids (no further details) were given at a bolus dose of 500 mg in the perioperative period followed by tapered doses of 15‐20 mg/day during month 1, 10‐15 mg/day during month 2, 5‐10 mg/day during month 3, then discontinued | |
| Outcomes | Outcomes reported: mortality at maximal follow‐up, graft failure at maximal follow‐up, any adverse events (number of people), graft rejection (any), graft rejection (requiring treatment) Follow‐up (months): 12 | |
| Notes | Source of funding (quote): "Astellas Pharma Europe Ltd. provided funding for the study" 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) | Low risk | Quote: "RANCODE (version 3.6) was used to generate the randomization sequence" |
| Allocation concealment (selection bias) | Low risk | Quote: "Allocation to treatment arms was performed using sealed sequentially numbered randomization envelopes provided by the study sponsor" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "prospective, randomized, open‐label, parallel arm study" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "prospective, randomized, open‐label, parallel arm study" |
| 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 |