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 |
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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). |
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Outcomes |
Primary Outcome(s): Not reported Secondary Outcome(s): Not reported |
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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 |
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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 |
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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 |