Allen 2007.
| Study characteristics | ||
| Methods | Single‐centre, prospective, randomised trial Run‐in period: not specified Number of centres: 1 Location: Ireland |
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| Participants | Thirty‐seven OPCAB surgery patients were randomly allocated to control (retransfusion of unwashed shed blood) and treatment (retransfusion of washed shed blood or discarding of unwashed blood) groups. | |
| Interventions | Intervention: treatment group n = 18 (retransfusion of washed shed blood or discarding of unwashed blood) and control group n = 19 (retransfusion of unwashed shed blood) Control: in the control group, all cardiotomy suction blood was collected in a cardiotomy suction reservoir and returned to the patient after completion of the last graft. In the treatment group, this shed blood was either discarded (if < 500 mL total volume) or processed in a Dideco (Mirandola, Italy) compact cell saver and then returned to the patient. |
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| Outcomes | Circulating blood and urinary samples were obtained. In addition, in the treatment group, blood was withdrawn from the shed mediastinal blood before and after it was processed in the cell saver. Plasma samples were assayed for TNF‐α, IL‐8, and IL‐6, as well as the anti‐inflammatory cytokines, IL‐10, IL‐1ra, and TNF soluble receptor‐2 (TNFsr‐2). Samples were also assayed for serum creatinine. Shed mediastinal blood was assayed for TNF‐α, IL‐6, IL‐8, TNFsr‐2, fHB, and full blood count. Urinary samples were assayed for IL‐1ra, TNFsr‐2, creatinine,α‐1‐microglobulin, albumin, and β‐NAG. All cytokine kits were from RD Systems (Minneapolis, MN) and were sandwich enzyme‐linked immunosorbent assay kits. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were randomly allocated to control (retransfusion of unwashed shed blood) or treatment (retransfusion of washed shed blood or discarding of unwashed blood) using an a priori random number generation software (GraphPad StatMate; San Diego, CA). |
| Allocation concealment (selection bias) | Unclear risk | No description about allocation concealment, although it states that blood was processed in line with treatment allocation, suggesting that personnel were not blinded to the allocations. This is unlikely to have had a significant impact on the outcomes reported if they were aware of allocations, though. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information about blinding is provided. Information provided suggested no blinding occurred. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information. No information about blinding is provided. Information provided suggested no blinding occurred. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data are identified, and outcomes for all participants were reported. No participants were withdrawn from analysis. |
| Selective reporting (reporting bias) | Unclear risk | Expected outcomes from methodology were reported, as were outcomes one would expect from this study design. The study does note that it was not powered to detect clinical differences but that the treatment group had an increased requirement for Plt transfusion. The need for this and the transfusion in itself could introduce significant variation in the outcomes. |
| Other bias | Low risk | None noted |