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 |
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| 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 |
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| Interventions | Intervention group: MiECC, a fully heparinised closed‐loop CPB system (Bioline‐Jostra, Gretz, France) Control group: a standard CPB |
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| 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. |