Martin 2004.
| Methods | Generation of the allocation sequence: adequate, stratified by centre. Allocation concealment: adequate, central randomisation. Blinding: not performed. Follow‐up: adequate. Analysis: intention to treat. |
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| Participants | Country: USA, multiple centres. Language: English. Inclusion criteria: All male and female patients with hepatitis C virus, 18 years or older, undergoing primary isolated liver transplantation. Exclusion criteria / diagnoses: ABO blood group incompatibility, Hepatitis B virus, HIV, cancer, pregnancy, lactation. Allocation: tacrolimus n = 38; cyclosporin n = 41. |
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| Interventions | Tacrolimus protocol:
‐ started 12 hours after transplantation; from 0.1 to 0.15 mg/kg/d adjusted to maintain trough of 5 to 10 ng/mL for 1st 6 months and from 5 to 10 ng/ml for next 6 months. Cyclosporin protocol: ‐ cyclosporin formulation: microemulsion ‐ started 12 hours after transplantation; from 6 to 10 mg/kg/d adjusted to maintain trough of 200 to 250 ng/ml for first 6 months and 100 to 250 ng/ml for next 6 months: Concomitant immunosuppression: steroids all patients; azathioprine all patients. ‐ all patients received periop parenteral steroids which were tapered to 20 mg/d orally on day 6 and decreased to 5 mg/d at day 90 ‐ all patients received azathioprine ‐ 2 mg/kg/d tapered to 1 mg/kg/d by day 7 and then withdrawn gradually after 60 days ‐ no OKT3 was used for rejection. |
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| Outcomes | ‐ recurrence of histologically diagnosed hepatitis ‐ time to hepatitis C virus recurrence ‐ change in viral load ‐ graft survival ‐ patient survival ‐ biopsy‐proven rejection rate. | |
| Notes | Follow‐up: 12 months. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Low risk | A ‐ Adequate |