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 |
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| 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) |
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| 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 |
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| 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. |
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| 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. |
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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) | 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. |