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. 2023 Sep 8;2023(9):CD001888. doi: 10.1002/14651858.CD001888.pub5

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
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.
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.
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
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