McShane 1987.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: university teaching hospital, Dublin, Ireland Recruitment: recruitment and study dates not reported Maximum follow‐up: immediate postoperative |
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Participants | 41 participants undergoing cardiac surgery on CPB were randomly allocated to one of two groups: Saved blood group (Cell salvage/intervention group): N = 20. M:F 12:8. Mean age 56.4 (range 37 to 74) Donor blood group (Control/no cell salvage group): N = 21. M:F 16:5. Mean age 47.76 (range 15 to 64). No further demographic data are available and no formal between‐group baseline comparison has been performed. |
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Interventions |
Saved blood group (Cell salvage/intervention group): in the cell salvage group, all perioperative shed blood was aspirated into a reservoir, using a low pressure suction device (< 100 mmHg) to minimise haemolysis. This blood was heparinised by means of heparinised lactated Ringer's solution (heparin 30,000 µL), which was delivered continuously to the tip of the suction wand. The aspirated blood was stored in a cardiotomy reservoir where it was de‐foamed and filtered before being passed to the centrifuge bowl of the autotransfusion device. Here, it was centrifuged and washed with lactated Ringer's solution (1000 mL approximately) until the effluent or waste fluid was clear in colour. Thus, the red cells were saved, and plasma, debris, and other cells discarded. These red cells were then suspended in lactated Ringer's solution and pumped to a transfusion bag for reinfusion to the participant. Donor blood group (Control/no cell salvage group): received allogeneic blood transfusions only |
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Outcomes | Outcomes reported: mortality, time spent on bypass, length of stay | |
Notes |
Transfusion protocol: use of a transfusion protocol is not reported Prospective registration status: the study was published prior to 2010. Ethical approval: it is unclear whether the study was approved by an ethics committee or institutional review board. 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) | Unclear risk | Insufficient detail on randomisation method |
Allocation concealment (selection bias) | Unclear risk | Insufficient detail on allocation concealment |
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 | High risk | No transfusion protocol ‐ no detail on how decisions were made to transfuse |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | Unclear risk | Not applicable – no subjective outcomes of interest |
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 | Unclear risk | Not applicable – no subjective outcomes of interest |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Poorly described |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | High risk | Imbalance of operation types. No conflict of interest or funding statement |