Gunaydin 2009 (A).

Study characteristics
Methods	Prospective, randomised study Run‐in period: over a 10‐month period Study date: 2009 Number of study centres and locations: not specified
Participants	Forty patients undergoing CABG were prospectively randomised to one of two perfusion protocols (n = 20): Group 1, minimised extracorporeal circuits (Mini‐CPB); Group 2, CECCs. Mean age: 63.3 years Sex (female/male ratio): 10% High‐risk patients Inclusion criteria: EuroSCORE classification (6+) Exclusion criteria: coagulopathy, endocarditis, or inability to obtain informed consent
Interventions	Intervention group: minimised extracorporeal circuits (Mini‐CPB) (ROCsafe MPC, Terumo, Ann Arbor, MI, USA) (a minimised “closed‐loop” circulatory and respiratory support circuit) Control group: CECCs (Capiox SX18, Terumo, USA) with a roller pump (System 1, TCM Heat exchanger, Terumo, USA) via an open system (Capiox Cardiotomy Reservoir, Terumo, USA) with 40‐mm blood filter (AV6SV, Pall)
Outcomes	Primary outcomes: air handling (intraoperative microembolic signals (GME)), perioperative rSO2, need for conversion to CECC and any complication, mean number of distal anastomoses Secondary outcomes: inflammation (IL‐6 and C3a), WBC and Plt counts, serum CK‐MB, neutrophil CD11b/CD18 levels, free Hb haemodilution, lactate levels, haemolysis and clinical outcome (haemodynamic parameters), perfusion and cross‐clamp duration, intubation period, postoperative haemorrhage, the use of blood and FFP, incidence of arrhythmia, use of inotropic support, complications and infection, the duration of ICU stay and hospital stay, perioperative mortality, and Hct, erythrocyte, serum albumin, and globulin fractions Blood samples were collected at T1, after induction of anaesthesia (before administration of heparin); T2, TEG control; T3, 15 minutes after commencement of CPB; T4, before cessation of CPB (before protamine infusion); T5, 15 minutes after protamine reversal; and T6, ICU first POD at 8:00 a.m.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No randomisation method description
Allocation concealment (selection bias)	Low risk	Closed envelope allocation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Investigators were blinded (anaesthesia technicians collected data) to the allocation.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Investigators were blinded (anaesthesia technicians collected data) to the allocation; it is unclear whether assessment of outcomes was blinded, but plausible.
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)	Unclear risk	Haemolysis and infection parameters were not clearly assessed.
Other bias	Low risk	No funding was disclosed.