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. 2015 Dec 3;2015(12):CD009745. doi: 10.1002/14651858.CD009745.pub2

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
Participants Inclusion criteria: All potential cadaver renal allograft recipients
Exclusion criteria: Not clearly reported
  • Patients enrolled: 126

  • Patients randomised: 107


PRBCs group: 42
Leukocyte poor red cells group: 45
Mixed group: 20
  • Patients transfused: 107

  • Patients considered for the analysis: 107


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).
Interventions
  1. PRBCs group: PRBCs.

  2. Leukocyte poor red cells group: Leukocyte poor red cell (the timing of leukoreduction is not reported).


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).
Outcomes This RCT did not specify by primary or secondary outcomes.
  1. Panel reactive antibody (PRA) levels: percent of panel cells showing at least 20% lysis with patients' serum, regardless of serum dilution, as determined by the antiglobulin modification.

  2. Allograft and patient survival.

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
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.