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 |
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| 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 |
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| Outcomes |
Primary Outcome: Not reported Other Outcomes: Mortality/survival, infection (days or episodes), adverse events |
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| Definition of infection |
Febrile day ‐ Not reported Febrile episode ‐ Not reported Proven infection: Not reported |
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| 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 |
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| Notes |
Funding Sources: Grant #384 from the Ontario Cancer Treatment and Research foundation Conflict of Interests: Not reported |
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| 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 |