Farsak 2012 (C).

Study characteristics
Methods	Prospective, randomised study Run‐in period: over a 4‐year period Study dates: 19 November 2010; accepted 22 March 2011; published online 10 November 2011 Number of study centres and locations: single centre, Department of Cardiovascular Surgery, Bayindir Hospital, Sogutozu, 06530 Ankara, Turkey
Participants	Eight hundred seventy‐five participants were prospectively randomised to one of four perfusion protocols: Group 1, PMEA‐coated circuits + leucocyte filters (n = 214); Group 2, uncoated ECC + full Hammersmith aprotinin (n = 212); Group 3, PMEA‐coated ECC + leucocyte filters + full Hammersmith aprotinin (n = 199); and Group 4, control, no treatment (n = 250). Mean age: 62.25 years Gender (female/male ratio): 45.39% High‐risk patients Inclusion criteria: CABG (EuroSCORE 6+) Exclusion criteria: known coagulopathy, endocarditis, and the inability to obtain informed consent
Interventions	Intervention group: PMEA‐coated ECC + leucocyte filters + full Hammersmith aprotinin (10,000 KIU IV test dose, 2 million KIU aprotinin through a central line before sternotomy, and 500,000 KIU/h until the end of the operation) Control group: no treatment
Outcomes	IL‐2, C3a, CK‐MB, and lactate levels (CS blood); neutrophil CD11b/CD18; TaTc; complete blood count (Hb, Hct, erythrocyte, leucocyte [WBC], and Plt counts); PT; activated partial thromboplastin time and fibrinogen levels; and standard blood and urine biochemistry, especially total protein, albumin, and globulin fractions Perioperative clinical outcomes: haemodynamic parameters, perfusion and cross‐clamp duration, intubation period, postoperative haemorrhage, use of blood and plasma, incidence of arrhythmia, use of inotropic support, complications, Cr clearance, duration of intensive care unit and hospital stay, and perioperative mortality Plt function was evaluated by TEG (ROTEG, Pentapharm, Munich, Germany) during the operation. Blood samples were collected at times T1 (after the induction of anaesthesia); T2 (after heparin administration and before the initiation of CPB); T3 (15 minutes after CPB); T4 (before cessation of CPB); T5 (15 minutes after protamine reversal); and T6 (in the 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)	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 were reported, but no ITT 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	No authors of this study have a conflict of interest.