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. 2023 Oct 24;2023(10):CD013584. doi: 10.1002/14651858.CD013584.pub2

Sohn 2009 (B).

Study characteristics
Methods Single‐centre, prospective, randomised controlled trial
Run‐in period: from August 2007 to April 2008
Registration date: not available, published in 2009
Number of study centres and locations: single centre, authors from University of Saskatchewan, Saskatoon, Canada
Participants Patients from part B were included in this analysis (see Interventions).
A total of 78 participants undergoing elective CABG were assessed. The study was divided into four parts, i.e. A, B, C, and D. The number of participants was as follows – A: 20, B: 20, C: 19, and D: 19. There were 16 participants in each group, except for the control group (n = 14).
Mean age: 65 years
Sex (female/male ratio): 0.54
Low‐risk patients (elective CABG)
Inclusion criteria: elective CABG
Exclusion criteria: subjects who recently attended emergency or who suffered from any chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus, Crohn’s disease, and COPD
Interventions Part A: trillium‐coated circuits
Part B: Bioline‐coated circuits
Part C: PC‐coated circuits
Part D: PMEA‐coated circuits
Control: an uncoated circuit
Outcomes TNF‐α, IL‐6, and IL‐10
Samples collected before CPB, 6 hours after CPB, and 72 hours after CPB
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Authors state that patients were randomised, but process was not described: "…were randomly assigned to five groups with different biocompatible coated circuits".
Allocation concealment (selection bias) Unclear risk No details given around concealment of allocation
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not described, plausible for participants
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No clear details given
Incomplete outcome data (attrition bias)
All outcomes Low risk No trial group changes, no withdrawals, and no losses to follow‐up were reported, but no intention‐to‐treat analysis. Data from all the participants were included in the final analysis.
Selective reporting (reporting bias) Low risk All expected outcomes were reported properly.
Other bias Low risk One of the authors received a non‐industry‐funded scholarship.