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. 2015 Jun 29;2015(6):CD005341. doi: 10.1002/14651858.CD005341.pub3

Sutton 1982.

Methods Parallel RCT (recruitment period not reported). Multicentre (11 hospitals are part of the Toronto Leukemia study group and all sites may have participated) Country: Canada
Participants Inclusion criteria: Adults with acute myeloid leukaemia
Exclusion criteria: infection criteria for excluding people from the study not reported
Total randomised: N = 67
Total analysed: N = 65
Arm 1 (Granulocyte transfusions): randomised and analysed = 29 , Acute myeloid leukaemia = 29
Arm 2 (Control): randomised = 38, analysed = 36, Acute myeloid leukaemia = 36
Interventions Comparison between standard treatment and prophylactic granulocyte transfusions
Granulocyte dose: 0.9 x 1010 (0.2 to 0.5)
Granulocyte method of collection: intermittent flow centrifugation
Donor premedication: prednisolone
Initiation of granulocyte transfusions: Neutrophil count < 0.5 x 109/L
Frequency of granulocyte transfusions: Daily
Termination of granulocyte transfusions: until neutrophil count above 0.5 x 109/L
Outcomes Primary Outcome: Not reported
Other Outcomes:
Mortality/survival, infection (days or episodes), adverse events
Definition of infection Febrile day ‐ Not reported
Febrile episode ‐ Not reported
Proven infection: Not reported
Definition of neutropenia Not reported but the 'trigger' neutrophil count was 0.5 x 109/L
Co‐interventions Prophylactic antibiotics: not reported
Therapeutic antibiotics: participants received broad‐spectrum antibiotics as indicated
Therapeutic granulocyte transfusions: for documented bacterial septicaemia
Notes Funding Sources: Grant #384 from the Ontario Cancer Treatment and Research foundation
Conflict of Interests: Not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of sequence generation was not reported
Allocation concealment (selection bias) Unclear risk Method of allocation concealment was not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk It was not reported whether participants were blinded to the intervention. It was not reported whether clinicians or investigators were blinded to the intervention.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk It was not reported whether outcome assessors were blinded to the intervention
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Two participants both in the control group, were randomised but not included in the analysis, one because the records were lost and the other because the diagnosis was changed to acute lymphoblastic leukaemia. One participant in the control group was discharged with resistant disease and was lost to follow‐up
Selective reporting (reporting bias) Unclear risk The protocol was not available to assess whether any pre‐specified outcomes were not reported or outcomes were reported that were not pre‐specified
Other bias Unclear risk Although none were identified, it is difficult to rule out any significant bias due to insufficient reporting of the study