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 |
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| 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 |
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| 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 |
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| 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. |