Ford 1982.
Methods | Parallel RCT (recruitment period not reported). Single centre. Country: England | |
Participants |
Inclusion criteria: People over 15 years old with acute myeloid leukaemia undergoing induction chemotherapy Exclusion criteria: "afebrile, free of infection and not receiving antibiotics". Microbiological proof of absence of infection was required prior to commencing granulocyte transfusion therapy Total randomised: N = 49 Total analysed: N = 24 Arm 1 (Granulocyte transfusions): randomised = 26, analysed = 13 with acute myeloid leukaemia Arm 2 (Control): randomised = 23 , analysed = 11 with acute myeloid leukaemia |
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Interventions | Comparison between standard treatment and prophylactic granulocyte transfusions Granulocyte dose: 1.45 x 1010 (0.28 to 3.45) Granulocyte method of collection: intermittent flow centrifugation Donor premedication: dexamethasone Initiation of granulocyte transfusions: Day after the neutrophil count < 0.5 x 109/L Frequency of granulocyte transfusions: Alternate days Termination of granulocyte transfusions: Neutrophil count > 0.5 x 109/L |
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Outcomes |
Primary Outcome: Not reported 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 ‐ two temperatures greater than 38.0oC in 24 hours. Febrile episode ‐ a temperature greater than or equal to 38oC for greater than or equal to 4 hours in the absence of blood transfusion Proven infection ‐ a causative organism was cultured either from blood or infected site or there were clinical signs strongly suggestive of infection or pneumonia was identified by chest X‐ray changes and clinical signs or symptoms. |
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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 (Storring 1977). Therapeutic antibiotics: if a fever occurred lasting more than 4 hours intravenous tobramycin and carbenicillin (or flucloxacillin for identified skin sepsis) were administered. Therapeutic granulocyte transfusions: not given to control participants |
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Notes |
Funding Sources: Imperial Cancer Research Fund, Department of Medical Oncology and Department of Haematology, St Bertholomew Hospital, London 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 | High risk | It was not reported whether participants were blinded to the intervention. If participants received granulocyte transfusions, "patients needed no platelet support because of the coincidentally transfused platelets". Clinicians and investigators would therefore be able to tell whether patients were receiving granulocyte transfusions. |
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 | High risk | 49 participants were randomised, of whom 26 received granulocyte transfusions. 25 of the 49 participants were excluded from the analysis because they did not meet the criteria for study entry.
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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 identified, it is difficult to rule out any significant bias due to insufficient reporting of the study |