Vij 2003.
| Methods | Biologically randomised study (recruitment period not reported). Single centre. Country: USA | |
| Participants |
Inclusion criteria: people receiving an allogeneic peripheral blood stem cell transplant Exclusion criteria: infection criteria for excluding people from the study not reported Total allocated: N = 225 Total analysed: N = 225 Arm 1 (Granulocyte transfusions): allocated and analysed = 83, Acute leukaemia = 36, Non Hodgkins lymphoma = 17, Chronic myeloid leukaemia = 17, other = 13 Arm 2 (Control): allocated and analysed = 142, , Acute leukaemia = 61, Non Hodgkins lymphoma = 37, Chronic myeloid leukaemia = 18, other = 26 |
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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 not reported Granulocyte method of collection: continuous flow apheresis 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 Outcome: Not reported Other Outcomes: Incidence of CMV viraemia; median time to detection of CMV viraemia |
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| Definition of infection |
Febrile day ‐ Not reported Febrile episode ‐ Not reported Proven infection: Not reported |
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| Definition of neutropenia | Not reported | |
| Co‐interventions |
Prophylactic antibiotics: not reported Therapeutic antibiotics: not reported Therapeutic granulocyte transfusions: not reported |
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| Notes |
Funding Sources: the publication costs of the article were defrayed in part by part charge payment. Therefore and solely to indicate this fact, this article is hereby marked "advertisement" in accordance with 18 USC section 1734. 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 | Randomisation was biological, determined by the availability of an ABO‐compatible allogeneic peripheral blood stem cell donor. The same donor served as both the stem cell and granulocyte donor |
| 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 | Loss to follow‐up 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 | High risk | The publication costs of the article were defrayed in part by part charge payment, this article was marked as an "advertisement" in accordance with 18 USC section 1734. |