Gunaydin 2009 (C1).

Study characteristics
Methods	Prospective, randomised study Run‐in period: not specified Study publication date: 2009 Number of study centres and locations: not specified
Participants	Thirty‐eight participants were assessed in part C1 of this study; the 25 participants from the condensed, coated circuit group (Group 1) are presented in this comparison. Seventy‐five patients were randomly allocated into three groups (n = 25): Group 1, CondECC; Group 2, ECC; Group 3, CONT. Mean age: 60.28 years Sex (female/male ratio): 39.47% No high‐risk patients Inclusion criteria: reoperation for CAB surgery Exclusion criteria: coagulopathy or ongoing anticoagulation, steroid therapy, nonsteroidal anti‐inflammatory drugs or aspirin within 5 days preoperatively
Interventions	Intervention group: condensed dual‐function open/closed configuration circuit (CondECC) (US patent no: 6946099) with components tip‐to‐tip coated with PMEA (Capiox SX 18; Terumo Medical Corporation, Somerset, NJ, USA), shortened tubing and components, and a priming volume under 800 mL, including a centrifugal pump (Sarns Centrifugal System, CXSP45; Terumo) and a venous air removal device (US patent no.: 6852280) incorporated shunt which bypasses the reservoir for the closed configuration. CPB was instituted either on open configuration, with a hard‐shell venous reservoir (Capiox SX; Terumo) and cardiotomy (CXCRXA; Terumo), or closed configuration, with a flexible venous reservoir (CX‐VRA0401T2; Terumo). Control group: a roller pump (System 1; Terumo) and conventional open, uncoated circuits (Capiox SX 18; Terumo), with a hard‐shell venous reservoir (Capiox SX; Terumo) and cardiotomy (CXCRXA; Terumo)
Outcomes	Inflammatory mediators (IL‐2, C3a), CK‐MB, troponin T and flow cytometry (CD11b/CD18), complete blood count (Hb, Hct, erythrocyte, leucocyte [WBC], and Plt counts), PT, activated partial thromboplastin time, fibrinogen levels, haemodynamic parameters, perfusion and cross‐clamp duration, intubation period, postoperative haemorrhage, the use of blood and plasma, incidence of arrhythmia, use of inotropic support, complications and infection, the duration of ICU stay and hospital stay, perioperative mortality; standard blood and urine chemistry, especially serum albumin and globulin fractions; free plasma Hb Blood samples were collected at the following intervals: (T1) baseline – after induction of anaesthesia (before administration of heparin); (T2) TEG control; (T3) on CPB – 15 minutes after initiation of CPB; (T4) off CPB – before cessation of CPB; (T5) protamine – 15 minutes after reversal with protamine; (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: "Patients were randomly allocated to one of the three groups (closed envelope allocation) with the investigators blinded to the allocation."
Allocation concealment (selection bias)	Low risk	Closed envelope allocation: "Patients were randomly allocated to one of the three groups (closed envelope allocation) with the investigators blinded to the allocation."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The investigators were blinded to the allocation; it is unclear whether patients were blinded: "Patients were randomly allocated to one of the three groups (closed envelope allocation) with the investigators blinded to the allocation."
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	The authors declare they have no proprietary interest in the products or devices described in the article.