Ippoliti 1991.
| Methods | Comparison: polyclonal antibody (RATG) vs monoclonal antibody Trial design: single‐centre RCT, 2 parallel groups Language: English Type of publication: journal article Judgement of trial quality: high risk of bias Cross‐over between treatment groups: no Sample size calculation: not reported Intention to treat analysis: yes |
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| Participants | Setting: University of Pavia, Pavia, Italy Inclusion period: not reported Allocation: 30 consecutive participants: 15 participants, RATG n = 15; OKT3 n = 15 Sex ratio: RATG 12 (80%) men:3 (20%) women; OKT3 14 (93) men:1 (7%) women Mean age: RATG 45.2 ± 12.3 years; OKT3 45.6 ± 11.8 years Adult:paediatric participants: not reported Indication (no (%)): Ischaemic cardiac disease: RATG 7 (47%); OKT3 5 (33%) Dilated cardiomyopathy: RATG 6 (40%); OKT3 9 (60%) Vascular cardiac disease: RATG 2 (13%); OKT3 1 (7%) Inclusion criteria: participants undergoing heart transplantation Exclusion criteria: not specified |
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| Interventions | Intervention therapy: RATG, preoperatively 5 mg/kg iv; postoperatively 2.5 mg/kg iv for 7 days Control therapy: OKT3, preoperatively 10 mg iv; postoperatively 5 mg iv for 14 days Concomittant immunosuppressive treatment: cyclosporin, started preoperatively azathioprine, started preoperatively corticosteroids, started preoperatively |
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| Outcomes | Survival, rejection, adverse reactions, OKT3 antibodies, lymphocyte subsets, infections Follow‐up period: 6 months |
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| Notes | Endomyocardial biopsies in all participants according to the Stanford criteria Acute rejection; definition not specified Study designer: not reported Sources of funding: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised, no further details specified |
| Allocation concealment (selection bias) | Unclear risk | Randomised, no further details specified |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | No protocol was assessed, but the trial reported on mortality, rejection, adverse reactions, and infections |
| Other bias | Low risk | The trial appeared to be free of other components of bias |