Murphy 2005.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: university teaching hospital, Bristol, Avon, UK Recruitment: 16‐month period. Specific recruitment and study dates are not reported. Maximum follow‐up: duration of hospital stay |
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Participants | 61 participants undergoing cardiac surgery were randomly allocated to one of two groups: Autotransfusion group (Cell salvage/intervention group): N = 30. M:F 25:5. Mean (SD) age 62.3 (9.3) Control group: N = 31. M:F 23:8. Mean (SD) age 66.4 (7.6) The groups were balanced before surgery with regard to demographics and comorbidities, apart from a higher frequency of unstable angina symptoms in the auto‐transfusion group. |
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Interventions |
Autotransfusion group: cell salvage group (Dideco Compact autotransfusion system) underwent intraoperative cell salvage with autotransfusion of washed salvaged red blood cells at the completion of the operative procedure. All blood lost, from skin incision to skin closure, was salvaged via a single‐lumen suction tube flushed with heparinised saline and connected to the closed rigid collection chamber of the Dideco Compact autotransfusion device at high‐pressure suction. Before autotransfusion, the heparinised salvaged intraoperative blood underwent a washing process, with re‐suspension of the red blood cells in saline, to an Hct of approximately 0.6. This red blood cell suspension was then transferred to a sterile collecting bag that was disconnected from the autotransfuser and administered via a standard blood giving set. Salvaged washed red blood cells were autotransfused at the time of skin closure. Control group: control group received standard care without autotransfusion. |
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Outcomes | Outcomes reported: number of participants transfused allogeneic blood, volume of blood collected by the cell saver, volume of blood re‐transfused from the cell saver, number of participants transfused fresh frozen plasma (FFP), number of participants transfused platelets, blood loss, mortality, adverse events | |
Notes |
Transfusion protocol: the threshold for transfusion of allogeneic blood was a haemoglobin level < 8.0 g/dL or a haematocrit < 0.23. In participants with excessive blood loss and cardiovascular instability, blood was given at the discretion of anaesthetic or intensive care unit staff. Prospective registration status: the study was published prior to 2010. Ethical approval: the study received local ethics committee approval. Language of publication: English Trial funding: not reported Conflicts of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Method used to generate allocation sequences was adequate: participants were assigned to 1 of 2 randomised groups, autotransfusion or control, in a 1:1 ratio by using block randomisation. Allocations were generated by a card system and concealed in sealed opaque envelopes. |
Allocation concealment (selection bias) | Low risk | Method used to conceal treatment allocation was adequate: participants were assigned to 1 of 2 randomised groups, autotransfusion or control, in a 1:1 ratio by using block randomisation. Allocations were generated by a card system and concealed in sealed opaque envelopes. |
Blinding of participants and personnel (performance bias) Objective outcome: mortality | Low risk | Objective outcome (mortality) unlikely to be influenced by blinding |
Blinding of participants and personnel (performance bias) Subjective: transfusion protocol | Low risk | Transfusion protocol in place: the threshold for transfusion of homologous blood was haemoglobin < 8 g/dL or haematocrit < 0.23. |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | High risk | No blinding, assignment preoperatively, may have impacted on some care |
Blinding of outcome assessment (detection bias) Objective outcomes: mortality and transfusions | Low risk | Objective outcome (mortality) unlikely to be influenced by blinding |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | No blinding, may impact some outcomes, especially LOS |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants randomised are accounted for in the reported outcomes, appears to be ITT |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | Unclear risk | Some baseline imbalance that may impact cardiovascular outcome measures (the 2 groups were balanced before surgery with respect to demographics and comorbidity, apart from a higher frequency of unstable angina symptoms in the autotransfusion group). No info on funding or conflicts |