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. 2015 Jun 29;2015(6):CD005341. doi: 10.1002/14651858.CD005341.pub3

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
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
Outcomes Primary Outcome: Not reported
Other Outcomes:
Mortality/survival, fever (days or episodes), infection (days or episodes), antibiotic use, adverse events
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.
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
Notes Funding Sources: Imperial Cancer Research Fund, Department of Medical Oncology and Department of Haematology, St Bertholomew Hospital, London
Conflict of Interests: Not reported
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.
  • 12 participants were randomised but excluded from the study because fever or infection developed either before their neutrophil count fell below 0.5 (eight participants) or before the first granulocyte transfusion (4 participants)

  • 13 participants were randomised but excluded, the specific reason for not meeting the study criteria 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 Although none identified, it is difficult to rule out any significant bias due to insufficient reporting of the study