Belli 2001.
| Methods | Randomised clinical trial | |
| Participants | Country: Italy
Period of recruitment: 1997‐1999
Number randomised: 19
Post‐randomisation dropouts: not stated
Revised sample size: 19
Average age (years): not stated
Females: not stated
Primary transplantation: not stated
Reason for transplantation Alcohol‐related cirrhosis: not stated Viral‐related cirrhosis: not stated Autoimmune disease‐related cirrhosis: not stated HCC: not stated Others: not stated Maintenance immunosuppression used during induction immunosuppression: cyclosporin A plus azathioprine Altered immunosuppression after withdrawal: yes (azathioprine was dropped) |
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| Interventions | Group 1: anti‐thymocyte globulin (n = 8) Further details: Rabbit anti‐thymocyte globulin for 5 days (no further details on the dose, frequency) Group 2: anti‐thymocyte globulin + glucocorticosteroids (n = 11) Further details: rabbit anti‐thymocyte globulin for 5 days + glucocorticosteroids for 3 months (no further details on the dose, frequency) | |
| Outcomes | Outcomes reported: graft rejection (any) Follow‐up (months): 22 | |
| Notes | Source of funding: not stated 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) | Unclear risk | Comment: this information was not available |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: this information was not available |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: this information was not available |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: this is a three‐armed trial, but only two arms are eligible for inclusion in the review. There were post‐randomisation dropouts. The number of dropouts in each group and the reasons for dropouts were not reported |
| Selective reporting (reporting bias) | High risk | Comment: no pre‐published protocol was available and the authors did not report on mortality, graft loss, or adverse events |
| Other bias | Low risk | Comment: no other bias noted |