Benitez 2010.
| Methods | Randomised clinical trial | |
| Participants | Country: Spain
Period of recruitment: 2006‐2008
Number randomised: 37
Post‐randomisation dropouts: 0 (0.0%)
Revised sample size: 37
Average age (years): 52
Females: 7 (18.9%)
Primary transplantation: 37 (100.0%)
Reason for transplantation
Alcohol‐related cirrhosis: 25 (67.6%)
Viral‐related cirrhosis: 2 (5.4%)
Autoimmune disease‐related cirrhosis: 0 (0%) HCC: 9 (24.3%) Others: 11 (29.7%) Maintenance immunosuppression used during induction immunosuppression: tacrolimus Altered immunosuppression after withdrawal: no Other exclusion criteria:
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| Interventions | Group 1: anti‐thymocyte globulin + glucocorticosteroids (n = 21) Further details: anti‐thymoglobulin 9 mg/kg was started 2–3 h before transplantation and infused i.v. over a 6‐h period preceded by 500 mg methylprednisolone i.v. Group 2: glucocorticosteroids (n = 16) Further details: corticosteroids were administered as follows: 1 g methylprednisolone i.v. during the surgical procedure, 20 mg prednisone daily during the first post‐transplant month, and thereafter doses were tapered down until complete discontinuation during post‐transplant months 3– 6 | |
| Outcomes | Outcomes reported: mortality at maximal follow‐up, graft failure at maximal follow‐up, serious adverse events (number of events), graft rejection (any) Follow‐up (months): 12 | |
| Notes | Source of funding (quote): "This work was supported by grants from Fresenius Biotech GmbH, Astellas and by the Ministerio de Educaci on y Ciencia, Spain" Trial name/trial registry number: NCT00436722 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: "The randomization sequence was computed‐generated and kept in opaque sealed envelopes." |
| Allocation concealment (selection bias) | Low risk | Quote: "The randomization sequence was computed‐generated and kept in opaque sealed envelopes." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "prospective, randomized, open label, controlled trial" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "prospective, randomized, open label, controlled trial" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: there were no post‐randomisation dropouts |
| 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 | High risk | Comment: the dose of tacrolimus was different in the two groups |