Chen 2004.
| Study characteristics | ||
| Methods | Randomised controlled trial. Number of centres and blinding not stated | |
| Participants | 32 consecutive adult patients undergoing coronary artery bypass grafting (CABG) or heart valve operation (leukodepletion filter (LD) 16, control filter 16). Baseline characteristics: mean age 61 years, 81% male, 31 CABG, 1 valve replacement Inclusion: not stated Exclusion: prior cardiac operation, infection, emergency operation, congestive heart failure, acute myocardial infarction in past month, corticosteroid therapy, severe asthma, COPD |
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| Interventions | Identical anaesthetic and monitoring techniques were used in both groups. Median sternotomy, 300 units/kg sodium heparin intravenously prior to CPB using a disposable membrane oxygenator. Uncoated extracorporeal circuit. Moderate systemic hypothermia. Leukodepletion: Pall LG6 arterial line filter Control: standard arterial line filter (no detail) |
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| Outcomes | Intra‐operative: CPB time Total white blood cell count (WBC) 103/mm3,neutrophil count, plasma concentrations of P‐selectin, ICAM‐1, IL‐8, PECAM‐1, oxygen index (before and after CPB), duration of post‐operative intubation and mediastinal drainage (cumulative after 24hrs in ICU). Blood samples collected at 7 time points: 1. after anaesthesia before sternotomy, 2‐3. After 30 and 60 minutes of CPB, 4. five minutes after coronary reperfusion, 5. conclusion of CPB, 6‐7. two and 24 hours after cessation of CPB. |
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| Notes | No valve patients in the control group | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data reported for all patients |
| Selective reporting (reporting bias) | Low risk | All collected data reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |