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

Remadi 2006.

Study characteristics
Methods Prospective randomised study
Run‐in period: from 1998 to December 2003
Submitted: 15 January 2004
Accepted: 26 March 2005
Number of study centres and locations: single centre. South Hospital, Amiens Cedex 1, France
Participants Four hundred patients underwent elective CABG using a standard CPB (200 patients) or a Jostra MECC System (200 patients)
Mean age: 64.7 years
Sex (female/male ratio): 12%
No high‐risk population
Inclusion criteria: elective CABG
Exclusion criteria: renal dysfunction (Cr > 1.2 mg/dL) and re‐do procedures
Interventions Intervention group: MiECC, a fully heparinised closed‐loop CPB system (Bioline‐Jostra, Gretz, France)
Control group: a standard CPB
Outcomes Mortality rate, low‐cardiac‐output syndrome, inflammatory response, CRP, Hct and Hb rate, intraoperative transfusion rate, postoperative blood Cr and urea, haemodynamic data
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No mention of random sequence generation. However, there was no statistically significant difference in preoperative comorbidity between groups.
Allocation concealment (selection bias) Unclear risk No description of allocation concealment method used
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No mention of blinding of participants and personnel. However, because of the nature of the intervention, operating room and surgical team were aware of the circuit used for CPB.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No mention regarding blinding of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk No trial group changes, no withdrawals, and no losses to follow‐up reported, but no intention‐to‐treat analysis. Data from all the patients were included in the final analysis.
Selective reporting (reporting bias) Unclear risk Measures of systemic inflammatory response were not performed because the number of participants was too high.
Other bias Low risk The authors had no financial or conflict of interest relative to this work.