Amin 2008.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: District General Hospital, Colchester, Essex, UK Recruitment: May 2005 to December 2005 Maximum follow‐up: duration of hospital stay |
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Participants | 178 participants undergoing total knee replacement were randomised to one of two groups: Autologous retransfusion drain group (Cell salvage/intervention group): N = 92. M:F 43:49. Mean (range) age 70.3 (55.2 to 88.5) Standard vacuum drain group (Control/no cell salvage group): N = 86, M:F 39:47. Mean (range) age 70.4 (57.9 to 87.1) No formal test of baseline imbalance was performed to compare the groups and the authors do not comment on whether they were similar. |
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Interventions |
Autologous retransfusion drain group: cell salvage group (Bellovac ABT autotransfusion sytem) had the blood collection suction bellows connected to an autologous transfusion bag with a 200 mm filter and a one‐way valve. The transfusion bag was connected to a transfusion set with a 40 µm filter. The drain was opened 20 minutes after tourniquet release. The shed blood was returned to the participant after collecting up to 500 mL and no later than 6 hours after surgery. A maximum of 1200 mL was re‐transfused. Standard vacuum drain group: control group (standard vacuum drain) had blood collected in the vacuum drains discarded. |
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Outcomes | Outcomes reported: number of participants transfused allogeneic blood, hospital length of stay, adverse events | |
Notes |
Transfusion protocol: allogeneic blood was transfused if the haemoglobin level fell below 80 g/L, or if the participant developed clinical signs of anaemia, such as tachycardia and postural hypotension, in the presence of a haemoglobin level of 80 g/L to 100 g/L. Prospective registration status: the study was published prior to 2010. Ethical approval: the study was approved by the local ethics committee. 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 | Method used to generate allocation sequences was not described. |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes were used to conceal treatment allocation, but doesn't mention if they were opaque. |
Blinding of participants and personnel (performance bias) Objective outcome: mortality | Low risk | No objective outcomes reported (mortality unlikely to be affected by blinding if reported in future publications) |
Blinding of participants and personnel (performance bias) Subjective: transfusion protocol | Low risk | Transfusion protocol in place: allogenic blood was transfused if the haemoglobin level fell below 8 g/dL, or if the participant developed clinical signs of anaemia, such as tachycardia and postural hypotension, in the presence of a haemoglobin level of 8 g/dL to 10 g/dL. |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | Unclear risk | No mention of blinding of participants or personnel |
Blinding of outcome assessment (detection bias) Objective outcomes: mortality and transfusions | Low risk | No objective outcomes reported (mortality unlikely to be affected by blinding if reported in future publications) |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | No mention of blinding in manuscript |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Unclear patient flow; however, results state they analysed ITT |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | Unclear risk | No mention of funding or conflicts |