Farag 2017 (B).
| Study characteristics | ||
| Methods | Prospective, randomised study Run‐in period: not specified. Received January 2016; revised February 2016 Number of study centres: not specified. Authors affiliated with institutions in Germany and the UK |
|
| Participants | 60 consecutive adults undergoing CABG Mean age: 63.65 years Sex (female/male ratio): 13.33% No high‐risk population Inclusion criteria: not specified Exclusion criteria: not specified | |
| Interventions | Intervention group: operated on with ECC.O (Sorin, Italy). The ECC.O system comprised a small membrane oxygenator and centrifugal pump (Stockert, Sorin, Germany). Control group: CECC (Maquet); for CECC (group C), a membrane oxygenator with cardiotomy reservoir and a roller pump (Maquet) |
|
| Outcomes | Myocardial protection (TnT and CK‐MB); IL‐1b, IL‐6, IL‐10, TNF‐a, MIF, RAGE, and CD40L; need for blood transfusion; mechanical ventilation time; duration of ischaemic time; total duration of surgery; or the number of grafts and clinical outcomes (major adverse cardiac events) Arterial blood samples were collected at intervals before CPB (T0), 30 min after initiation (T1), after termination of CPB (T2), 6 h after CPB (T3), and 24 h after CPB (T4). | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Consecutive patients with comparable preoperative characteristics but no further randomisation method description |
| Allocation concealment (selection bias) | Unclear risk | No information around allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not specified |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specified |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No trial group changes, no withdrawals, and no losses to follow‐up reported, but no ITT analysis. Data from all the patients were included in the final analysis. |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported properly. |
| Other bias | Low risk | The authors declared no conflict of interest. |