Zhao 2003.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: university teaching hospital, Beijing, China Recruitment: January 2000 to October 2000 Maximum follow‐up: not reported |
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Participants | 60 participants undergoing elective primary coronary artery bypass graft surgery were randomly allocated to one of two groups: Group 1 (Shed mediastinal blood) (cell salvage/intervention group): N = 30. M:F 26:4. Mean (SD) age 59.5 (8.0) Group 2 (Banked blood only) (control/no cell salvage group): N = 30. M:F 27:3. Mean (SD) age 59.2 (8.2) There were no differences between groups at baseline assessment. |
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Interventions |
Group 1 (Shed mediastinal blood) (cell salvage/intervention group): cell salvage group participants received non‐washed shed mediastinal blood re‐transfused postoperatively after CABG using a cell saver device (Beijing PerMed Biomedical Engineering Company) up to 18 hours post‐surgery. Shed blood not returned within 4 hours was discarded and a new bag attached. When > 200 mL of shed mediastinal blood was collected within 4 hours, the patients received autologous blood if volume replacement was considered necessary. Extracorporeal blood was routinely returned to patients after CABG. Group 2 (Banked blood only) (control/no cell salvage group): control group received banked allogeneic blood only. Autotransfusion was not used. Extracorporeal blood was routinely returned to patients after CABG. |
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Outcomes | Outcomes reported: number of participants transfused allogeneic blood, volume of allogeneic blood transfused, number of participants transfused autologous blood, volume of autologous blood transfused, blood loss | |
Notes |
Transfusion protocol: the use of a transfusion protocol for allogeneic blood transfusion was not reported. Prospective registration status: the study was published prior to 2010. Ethical approval: it is not clear 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 | 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 | High risk | No protocols; no blinding |
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 | High risk | No protocols; no blinding |
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 | No baseline imbalance. No mention of funding or conflicts of interest |