Zhao 2017.
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, single‐centre study Setting: specialist cardiac surgery hospital, Zhengzhou, China Recruitment: August 2012 to January 2013 Maximum follow‐up: duration of hospital stay |
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Participants | 120 participants with coronary heart disease scheduled for elective, primary, three‐vessel CABG using 3 to 6 grafts. Enroled participants were randomly allocated to one of the following two groups: Experimental group (cell salvage/intervention group): N = 60. M:F 39:21. Mean (SD) age 60.48 (9.22) Control group: N = 60. M:F 37:23. Mean (SD) age 59.26 (7.45) The groups were comparable at baseline assessment. |
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Interventions |
Experimental group (cell salvage/intervention group): participants in the experimental group (autologous group) underwent blood cell salvage intraoperatively using the Dideco Electa blood cell separator (Sorin Group, Italy) and a disposable kit. Blood salvaged from the surgical field was collected using negative pressure suction apparatus and then washed prior to re‐transfusion. Control group: participants in the control group did not undergo blood cell salvage and autotransfusion and were transfused with allogeneic blood as required. |
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Outcomes | Outcomes reported: number of units of allogeneic red blood cell transfusion, volume (mL) of allogeneic blood plasma transfusion, ICU retention time, complications, endotracheal intubation, postoperative hospital stay, average hospitalisation cost | |
Notes |
Transfusion protocol: a haemoglobin level < 8 g/dL was considered the standard for all patients. Prospective registration status: the study was not prospectively registered with a trials registry. Ethical approval: the study was approved by the Ethics Committee of Henan Province People’s Hospital. 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 | The randomisation methodology is not described. |
Allocation concealment (selection bias) | Unclear risk | The method of allocation concealment is 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 | Low risk | Transfusion protocol in place: a haemoglobin level < 8 g/dL was considered the standard for all patients |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | High risk | The blinding status of study participants and personnel is 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 | High risk | The blinding status of outcome assessors is not described. Blood loss measurement could lead to significant variability |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number contributing to outcomes is not clear |
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 |