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. 2016 Apr 29;2016(4):CD005339. doi: 10.1002/14651858.CD005339.pub2

Scali 1978.

Methods Parallel RCT (Between 1973 and 1977) (number of centres not reported) Switzerland
Participants Acute leukaemias and predominantly acute myeloid leukaemia (as first treatment i.e. not refractory and not relapsed)
Inclusion criteria: Patients with acute leukaemia or blastic phase of chronic myeloid leukaemia if the neutrophil count was < 0.25 x 109/L, and if infection was documented or strongly suspected. The eligibility criteria for children also required culture‐positive microbiology results.
Exclusion criteria: No patient was eligible unless he was under treatment for acute leukaemia
Age range not reported
N = 25 patients included in the analysis, Acute myeloid leukaemia = 23, Acute lymphocytic leukaemia = 2. All participants were receiving induction chemotherapy
Arm 1 (Granulocyte transfusions): N = 13
Arm 2 (Control): N = 12
Interventions Granulocyte dose: average 2.9 x 1010 granulocytes given/day to each patient. Total dose received by patients from all transfusions 6.6 x 1010, range 1.7 to 14.7 x 1010
Granulocyte method of collection: continuous flow (cell separator) centrifugation
Selection of donors: ABO‐compatible
Pre‐medication of donors: not reported
Initiation of granulocyte transfusions: neutropenia < 0.5 x 109/L & fever > 380C (at least 3 out of 4 measurements in 24 hours) & antibiotics given for more than 24hrs without response or recurrence after initial improvement & hypocellular bone marrow aspirate
Frequency of granulocyte transfusions: Daily
Termination of granulocyte transfusions: Not reported. Granulocytes were given for a total mean number of 2.7 days (range 1 to 5 days).
Outcomes Primary Outcome(s): Not reported
Secondary Outcome(s): Not reported
Definition(s) of infection Infections were retrospectively divided into: clinically and microbiologically documented; clinically definite source of infection (e.g. severe soft tissue infection even if no fever), and fever of unknown origin.
Definition of neutropenia Neutrophil count < 0.5 x 109/L
Co‐interventions Therapeutic antibiotics: All patients received gentamicin: in 21 cases this was combined with cephalothin or carbenicillin, or both; in 4 cases it was combined with other antibiotics.
G‐CSF: G‐CSF not licensed by the Food and Drug Administration (FDA) until 1991.
Therapeutic antifungals: Not reported
Notes Randomised: Patients were not randomised until antibiotics were started for presumed or proven infection and a bone marrow aspirate had been performed that showed a pronounced hypocellularity or a complete aplasia with lack of myelopoiesis.
Trial registration: none identified
Sources of funding: Not reported
Conflicts of Interest: Not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomisation not reported
Allocation concealment (selection bias) Unclear risk Method of allocation concealment not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear whether there was loss to follow‐up
Selective reporting (reporting bias) Unclear risk No protocol was available
Other bias Unclear risk Study is poorly reported, therefore the study may be at significant risk of bias. The more serious infections extending sepsis, pneumonia and soft tissue abscesses were unequally distributed between the two groups and overall were more common in the granulocyte transfusion group