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. 2006 Oct 18;2006(4):CD005161. doi: 10.1002/14651858.CD005161.pub2

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.
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.
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 ‐ all patients received azathioprine ‐ 2 mg/kg/d tapered to 1 mg/kg/d by day 7 and then withdrawn gradually after 60 days 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.
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