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

Schiffer 1979.

Methods Parallel RCT (recruitment period not reported). Single centre. Country: USA
Participants Inclusion criteria: Previously untreated adults (> 18 years) with acute myeloid leukaemia.
Exclusion criteria: excluded infected patients and patients on systemic antibiotics
Total randomised: N = 22
Total analysed: N = 18
Arm 1 (Granulocyte transfusions): randomised = 12, analysed = 9 , Acute myeloid leukaemia = 12
Arm 2 (Control): randomised = 10, analysed = 9 , Acute myeloid leukaemia = 10
Interventions Comparison between prophylactic platelet transfusions on alternate days (3 to 4 out of 7 days) versus prophylactic granulocyte and platelet transfusions on alternate days (4 out of 7 days)
Granulocyte dose: 1.15 x 1010 (0.34 to 2.4)
Granulocyte method of collection: intermittent flow centrifugation
Donor premedication: dexamethasone
Initiation of granulocyte transfusions: Neutrophil count < 0.5 x 109/L or platelet count < 20 x 109/L
Frequency of granulocyte transfusions: Four days out of seven each week
Termination of granulocyte transfusions: Until recovery (or rising neutrophil count > 0.5 x 109/L with no dependence on platelet transfusions
Outcomes Primary Outcomes: Microbiologically or clinically documented severe infection and detected alloimmunisation
Other Outcomes:
Mortality/survival, fever (days or episodes), infection (days or episodes), antibiotic use, adverse events
Definition of infection Febrile day ‐ not reported
Febrile episode ‐ temperature > 38.3oC
Proven infection: ‐ not reported
Definition of neutropenia Not reported but the 'trigger' neutrophil count was 0.5 x 109/L
Co‐interventions Prophylactic antibiotics: all participants received oral non‐absorbable antibiotics
Therapeutic antibiotics: empirical systemic antibiotics were started if the temperature was > 38.3oC and / or there was clinical evidence of infection but the nature of these antibiotics were not stated.
Therapeutic granulocyte transfusions: not reported
Notes Funding Sources: Not reported
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 Unclear risk Ten participants were randomised to the control. One participant developed alloimmunisation after her first platelet transfusion and was not continued in the study. 12 participants were randomised to receive granulocyte transfusions. Two participants developed infections prior to receiving their first granulocyte transfusion and were excluded from the study. A third participant refused further granulocyte transfusions after two severe transfusion reactions.
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 Two participants in the control group had acute promyelocytic leukaemia and developed disseminated intravascular coagulation. This could have increased the risk of mortality in the control arm.