Strauss 1981.

Methods	Parallel RCT (recruitment period not reported). Multicentre, four clinical centres. Country: USA
Participants	Inclusion criteria: people with untreated acute leukaemia who were at least 12 years old, and were "found by examination, chest roentgenography, urinalysis and cultures of blood and urine to be free of infection" Exclusion criteria: people with an infection Total randomised: N = 102 Total analysed: N = 102 Arm 1 (Granulocyte transfusions): randomised and analysed = 54, Acute myeloid leukaemia = 54 Arm 2 (Control): randomised and analysed = 48 , Acute myeloid leukaemia = 48
Interventions	Comparison between standard treatment and prophylactic granulocyte transfusions Granulocyte dose: Median dose 0.34 x 1010/m2 Granulocyte method of collection: intermittent flow centrifugation Donor premedication: none Initiation of granulocyte transfusions: Neutrophil count < 0.5 x 109/L Frequency of granulocyte transfusions: Daily Termination of granulocyte transfusions: For 28 days, or until bone marrow recovery defined as a neutrophil count above 0.5 x 109/L for 48 hours. death, a severe transfusion reaction, withdrawal of the patient's consent, or gram negative septicaemia
Outcomes	Primary Outcome: Documented infection Other Outcomes: Mortality/survival, infection (days or episodes), antibiotic use, adverse events
Definition of infection	Febrile day ‐ not reported Febrile episode ‐ fever was defined as an oral temperature above 38oC, unrelated to transfusions, that was recorded on two separate occasions separated by at least four hours during a 24 hour period. Septicaemia: culture of an organism from the blood of patients with fever Pneumonia: fever plus either a localised infiltrate or cavity seen on chest X‐ray Urinary tract infection: fever and the isolation of a single pathogenic organism (≥ 100,000 colonies per millilitre) Cellulitis: fever plus and inflammatory lesion ≥ 9cm in diameter Abscess: ≥ 4cm in diameter with either a fluctuant mass or drainage from which a single organism was cultured
Definition of neutropenia	Not reported but the 'trigger' neutrophil count was 0.5 x 109/L
Co‐interventions	Prophylactic antibiotics: not given Therapeutic antibiotics: systemic carbenicillin or ticarcillin plus an aminoglycoside if a participant suffered two temperatures >38.5oC in 24 hours. Therapeutic granulocyte transfusions: if participants in the control group acquired gram‐negative septicaemia
Notes	Funding Sources: National Heart, Lung and Blood Institute; the National Cancer Institute; Masonic Hospital Fund Incorporated; the Minessota Medical Foundation. Conflict of Interests: Not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Separate randomisation schedules were prepared for each institute and stratum. An algorithm that ensured an approximate balance between treatment groups was used to generate each schedule.
Allocation concealment (selection bias)	Low risk	By a telephone call to the co‐ordinating centre, participants were randomly assigned to receive daily granulocyte transfusions or not to receive them.
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	Participants were monitored and data were collected daily by personnel trained by the co‐ordinating centre but it was unclear whether these outcome assessors were blinded to the intervention.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Loss to follow‐up was not reported
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	A policy and data‐monitoring board, composed of scientists from institutions not participating in the trial was appointed by the NHLBI to review the study results periodically. Randomisation into the study was terminated in the basis of this review by recommendation of the policy board, but the reason for the recommendation was not reported.