Westerberg 2004.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: university teaching hospital, Gothenburg, Sweden Recruitment: recruitment and study dates not reported Maximum follow‐up: 12 hours postoperatively |
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Participants | 35 participants undergoing cardiac surgery were randomly allocated to one of two groups: Retransfusion group (cell salvage/intervention group): N = 12. M:F 9:3. Mean (SD) age 64 (7.0) No retransfusion group (control/no cell salvage group): N = 17. M:F 16:1. Mean (SD) age 67 (8.3) There was imbalance between groups in aortic cross‐clamp time and CPB time. All other demographic and baseline data were comparable between groups. NB: 6 participants were excluded from the final analysis. |
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Interventions |
Retransfusion group (cell salvage/intervention group): autotransfusion group had their cardiotomy suction blood during cardiopulmonary bypass (CPB) and mediastinal shed blood during the first 12 hours postoperatively re‐transfused. No retransfusion group (control/no cell salvage group): control group had their cardiotomy suction blood and mediastinal shed blood discarded. NB: all participants received intravenous tranexamic acid (TXA) 2 g before surgery and 2 g after skin closure. |
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Outcomes | Outcomes reported: number of participants transfused allogeneic blood, volume of shed mediastinal blood, blood loss | |
Notes |
Transfusion protocol: the use of a transfusion protocol was not reported. Prospective registration status: the study was published prior to 2010. Ethical approval: the study protocol was approved by the Research Ethics Committee of the Medical Faculty, University of Gothenburg. Language of publication: English Trial funding: Gothenburg Medical Association 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 not described. |
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 | High risk | No transfusion protocol in place |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | Unclear risk | The blinding status of participants and personnel was not described. |
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 | The blinding status of outcome assessors was not described. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 35 randomised, 29 analysed ‐ 6 excluded but seems wrong to exclude them. Nearly 20% excluded; appears to be imbalanced (more excluded from re‐transfusion group) |
Selective reporting (reporting bias) | Unclear risk | No trial registration or published protocol is available to compare |
Other bias | Unclear risk | Minor baseline imbalance, likely due to unbalanced exclusions (did it impact males in the retransfusion group only). Funding reported (non‐pharmaceutical) |