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 |
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| 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 |
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| 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 |
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| Definition of infection |
Febrile day ‐ not reported Febrile episode ‐ temperature > 38.3oC 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: 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 |
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| Notes |
Funding Sources: Not reported 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 | 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. |