Thomas 2001.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: regional hospital, Swansea, Wales, UK Recruitment: recruitment and study dates not reported Maximum follow‐up: 7 days postoperatively |
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Participants | 231 participants undergoing elective total knee replacement surgery were randomly allocated to one of two groups: Autologous (cell salvage/intervention group): N = 115. M:F 44:71. Mean age of males 67.4 years; mean age of females 70.5 years Allogeneic (control/no cell salvage group): N = 116. M:F 55:61. Mean age of males 69.7 years; mean age of females 70.2 years Groups were comparable at baseline assessment. |
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Interventions |
Autologous (cell salvage/intervention group): cell salvage group participants received autotransfusion of wound drainage if the volume of blood collected was > 125 mL postoperatively. The collected blood was washed and re‐suspended in saline before re‐infusion using a centrifugal cell washing machine (Haemonetics Cell Saver 5). Participants in the cell salvage group were transfused allogeneic red blood cells if their haemoglobin fell below a haemoglobin level of 9.0 g/dL after autotransfusion was completed. Allogeneic (control/no cell salvage group): control group were treated without the use of cell salvage (autotransfusion). All drainage blood was discarded. |
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Outcomes | Outcomes reported: number of participants transfused allogeneic blood, amount of allogeneic blood transfused, adverse events | |
Notes |
Transfusion protocol: allogeneic blood was transfused if the haemoglobin level fell below 9.0 g/dL. Prospective registration status: the study was published prior to 2010. Ethical approval: the study was approved by the local research ethics committee. Language of publication: English Trial funding: Welsh Office for Research and Development in Health and Social Care 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 | Method used to conceal treatment allocation was unclear. |
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: pre‐set transfusion trigger of 9 g/dL. The participants in the cell salvage group were also transfused if their haemoglobin fell below the preset trigger after autotransfusion. |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | Unclear risk | Adverse events were scrutinised in a blinded fashion to determine those possibly related to transfusion effect (wound infection, embolic events, MI, and cardiopulmonary (CP) complications). Appears to be based on the recordings taken by a research nurse ‐ no protocols described and no mention of whether the research nurse was blinded. |
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 | Adverse events were scrutinised in a blinded fashion to determine those possibly related to transfusion effect (wound infection, embolic events, MI, and CP complications). Appears to be based on the recordings taken by a research nurse ‐ no protocols described and no mention of whether the research nurse was blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | ITT analysis |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | Low risk | No baseline imbalance. Funding reported (non‐pharmaceutical) |