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. 2023 Oct 24;2023(10):CD013584. doi: 10.1002/14651858.CD013584.pub2

Gunaydin 2007 (A).

Study characteristics
Methods Prospective, randomised study
Run‐in period: not specified
Study publication date: 2007
Number of study centres and locations: not specified
Participants Forty participants were assessed in part A of this study, including the high‐risk group.
One hundred twenty participants were allocated into two groups (n = 60): Group 1 – PMEA‐coated circuits + leucocyte filters (Terumo, USA); Group 2 – control, uncoated circuits (Terumo, USA). Each group was further divided into three subgroups (n = 20) with respect to low‐ (EuroSCORE 0 to 2), medium‐ (3 to 5), and high‐risk (6+) patients.
Inclusion criteria: CABG
Exclusion criteria: coagulopathy, endocarditis, and inability to obtain informed consent
Interventions Intervention group: high‐risk patients, PMEA‐coated circuits (Capiox SX 18®, Terumo Medical Corporation, Ann Arbor, MI, USA) + leucocyte filters (LG6B and BC2, Pall Biomedical Products, East Hills, NY, USA)
Control group: uncoated circuits (Capiox SX 18®, Terumo Medical Corporation, Ann Arbor, MI, USA)
Outcomes Heart injury, AF, IL‐2, C3a, CK‐MB, complete blood count (Hb, Hct, erythrocyte, leucocyte (WBC), and Plt counts), PT, activated partial thromboplastin time, lactate levels, neutrophil and monocyte CD11b/CD18, phagocytic capacity of fibres; 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, duration of ICU and hospital stay, perioperative mortality
Blood samples were obtained from radial artery and CS blood at the following intervals: T1, baseline – after induction of anaesthesia (before administration of heparin); T2, after heparin administration and before the initiation of CPB (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: "In a prospective randomized study, 120 patients undergoing coronary artery bypass grafting (CABG) were allocated into two groups"
Allocation concealment (selection bias) Unclear risk No allocation concealment information
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants' blinding unspecified, personnel blinded: "The operating room and intensive care unit staff collecting data were blinded to the entire study."
Blinding of outcome assessment (detection bias)
All outcomes Low risk Not specified for outcome assessors, data collectors blinded: "The operating room and intensive care unit staff collecting data were blinded to the entire study."
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 Baseline, clinical, and inflammatory outcomes were not reported properly for each group.
Other bias Unclear risk No funding was disclosed.