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

Oza 2006.

Methods Biologically randomised study (recruitment period not reported). Single centre. Country: USA
Participants Inclusion criteria: People aged at least 15 years of age undergoing related HLA‐matched allogeneic haematopoietic stem cell transplantation
Exclusion criteria: infection criteria for excluding people from the study was not reported
Total cohort N = 151
Arm 1 (Granulocyte transfusions): Allocated and analysed N = 53 Leukemia = 38; Lymphoroliferative disorders = 15
Arm 2 (Control): Allocated and analysed = 98; Leukaemia = 59, Lymphoroliferative disorders = 39
Allograft BMT, acute leukaemia
Interventions Comparison between standard treatment and prophylactic granulocyte transfusions
Granulocyte dose: participants received two granulocyte transfusions. The mean dose and range were given separately for the first dose, 5.9 x 1010 (0.02 to 15.5) and the second dose 5.2 x 1010 (0.02 to 21.0)
Granulocyte method of collection: intermittent flow centrifugation
Donor premedication: G‐CSF
Initiation of granulocyte transfusions: Day plus 3 or 5 (depending on protocol)
Frequency of granulocyte transfusions: Twice during neutropenic interval
Termination of granulocyte transfusions: Day plus 6 or 7 (depending on protocol)
Outcomes Primary Outcomes: The number of febrile days and days of intravenous antibiotic use during the initial transplant hospitalisation period
Secondary Outcomes:
Mortality/survival, fever (episodes), antibiotic use, adverse events
Definition of infection Febrile day ‐ Any day during the initial hospitalisation that the recipient’s temperature was 38.3°C
Febrile episode ‐ Temperature of at least 38.3oC
Proven infection: Documented bacteraemia included only culture‐proven systemic blood infections for either gram‐positive or gram‐negative bacteria.
Definition of neutropenia Neutrophil count < 0.5 x 109/L
Co‐interventions Prophylactic antibiotics: not given
Therapeutic antibiotics: IV vancomycin and imipenem as empirical treatment for infection.
Therapeutic granulocyte transfusions: not reported.
Notes Funding Sources: Not reported
Conflict of Interests: Not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Participants were allocated to the intervention arm dependent on ABO‐matching and donor's ability to donate granulocytes. "Donor‐recipient pairs that were ABO‐matched were assigned as potential candidates for Cohort G (Granulocyte transfusions), whereas those that were not ABO‐matched were assigned to Cohort C (control). Donor‐recipient pairs assigned as potential candidates for Cohort G remained in Cohort G if the donors also satisfied the criteria to donate granulocytes. Otherwise, these donors were reassigned to Cohort C. ABO mismatch included major (donor‐recipient ABO typing of A‐O, B‐O, AB‐O, AB‐B, and AB‐A, respectively) and bidirectional (donor‐recipient ABO typing of A‐B and B‐A, respectively) mismatches."
Allocation concealment (selection bias) High risk Treatment allocation was dependent on availability of an appropriate granulocyte donor
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 It was unclear whether any participants were 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 High risk In the control group 26 participants were ABO mis‐matched, 14 participants had CMV mis‐match with their donors. CMV mis‐match could have increased the risk of CMV infection in the recipient. 17 donors underwent more than 1 PBSC collection and were therefore not eligible as granulocyte donors.