Hurst 1997.
| Study characteristics | ||
| Methods | Randomised controlled trial. Single centre, investigators blinded to intervention | |
| Participants | July 1993‐Jun 1994 24 adult patients electively undergoing open heart valve surgery (leukodepletion filter (LD) 11, control filter 13) Baseline characteristics: mean age 62 years, 46% male, all valve surgery. EF<50% 9 pts, 13 pts cough, 11 pts past smoker, 22 pts dyspnoea grade 1‐4 Inclusion: not stated Exclusion: informed consent unobtainable, emergency surgery |
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| Interventions | All patients followed to discharge. Surgery and anaesthesia according to usual practice of 2 participating surgeons. Systemic cooling to 24‐28°C. No CPB details Leukodepletion: Pall LG6 arterial line filter Control: Pall Autovent SP filter |
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| Outcomes | Intra‐operative: aortic cross‐clamp time, CPB time, fluid balance, mediastinal blood loss Haemodynamics and blood samples, pre‐op, after anaesthetic induction, at aortic x‐clamp, 1/4/24 hrs post‐op. systemic arterial pressure, right arterial pressure, pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac index, blood gases, oxygen saturation, WBC count, neutrophil count, platelet count, IL‐6SR, CD11b, CD18. Weight, chest x‐ray, fluid balance, FEV1 & FVC on 2nd and 5th post‐op day and discharge. Echocardiography, fractional shortening, ejection fraction, wall motion abnormalities and atelectasis measured pre‐op and on discharge. Number of MIs. |
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| Notes | ||
| 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 | Unclear risk | Number of patients per outcome or withdrawal and completion rates not reported |
| Selective reporting (reporting bias) | Unclear risk | All collected data reported |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Investigators blinded to intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Some outcome assessments blinded (atelectasis and wall motion) |