Sanfilippo 1985.
Methods | Design: Parallel group RCT Country: USA Multicentre study: No Setting: Hospital Follow‐up: 1 year Unit of allocation: Patients Unit of analysis: Patients |
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Participants | Inclusion criteria: All potential cadaver renal allograft recipients Exclusion criteria: Not clearly reported
PRBCs group: 42 Leukocyte poor red cells group: 45 Mixed group: 20
Main characteristics of patients included in full analysis were not fully stated: Quote: "there were no significant differences between transfusion groups in terms of demographic factors, including number of transfusions, age, race, sex, degree of HLA match, number of diabetics or the use of ATG posttransplant" (Page 117). |
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Interventions |
Cointerventions: "All transplant recipients received conventional maintenance immunosuppressive therapy with azathioprine and prednisone, and antithymocyte globulin (ATG) and/or bolus methylprednisolone was used for the treatment of rejection episodes" (Page 117). |
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Outcomes | This RCT did not specify by primary or secondary outcomes.
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Notes | Trial registration: Not reported. Funding: National Kidney Foundation of North Carolina Role of sponsor: Not stated A priori sample size estimation: No Conducted: Between September 1980 and June 1982 Declared conflicts of interest: Not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...after obtaining informed consent, patients were randomly assigned to receive" (Page 116). Comment: Insufficient information to permit judgement of ‘low risk’ or ‘high risk’. |
Allocation concealment (selection bias) | Unclear risk | Quote: "...after obtaining informed consent, patients were randomly assigned to receive..." (Page 116). Comment: Insufficient information to permit judgement of ‘low risk’ or ‘high risk’. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Insufficient information to permit judgement of ‘low risk’ or ‘high risk’. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Insufficient information to permit judgement of ‘low risk’ or ‘high risk’. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: Insufficient information to permit judgement of ‘low risk’ or ‘high risk’. |
Selective reporting (reporting bias) | High risk | Comment: The study report fails to include results for a key outcome that would be expected to have been reported for such a study. |
Other bias | High risk | Design bias. |