| Inflammatory organ injury, sepsis or death |
▸ Sepsis will be defined as antibiotic treatment for suspected infection, and the presence of SIRS within 24 h prior to start of antibiotic treatment where SIRS is defined as ≥2 of the following conditions: temperature >38oC or <36oC; heart rate >90 bpm; respiratory rate >20 breaths/min or PaCO2 <32 mm Hg; white cell count >12 000/mm3 or <4000/mm3, or antibiotic treatment for wound infection.36 ▸ Acute kidney injury, defined as KDIGO32 stage 1, 2 or 3. ▸ Acute lung injury, defined as PaO2/FiO2 ratio <300 mm Hg or a requirement for respiratory support; invasive ventilation>48 h, non-invasive ventilation>4 h, reintubation, tracheostomy, or ARDS.37 ▸ Low cardiac output, defined as new intraoperative or postoperative intra-aortic balloon pump insertion OR a cardiac index of <2.2 L/min/m2 measured using a Swann Ganz catheter that is refractory to appropriate intravascular volume expansion after correction or attempted correction of any dysrhythmias, OR the administration of inotropes including dobutamine, enoximone, milrinone, levosimendan and adrenaline. ▸ Death. ▸ Differences in Multiple Organ Dysfunction Score38 at days 1, 2, 3 and 5.
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| Bleeding and transfusion |
▸ Measured blood loss in drains at 6 h postoperatively. ▸ The number of units of RBC and other blood components transfused during the operative period and postoperative hospital stay will be recorded. ▸ Age of each unit of RBC transfused. ▸ Serial haemoglobin levels/haematocrit.
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| Transfusion reactions |
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| Other clinical outcomes |
▸ Stroke; diagnosed by brain imaging (CT or MRI), in association with new onset focal or generalised neurological deficit (defined as deficit in motor, sensory or coordination functions). ▸ ST elevation myocardial infarction accompanied by troponin I >5000 pg/mL.
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| Hospital stay, cumulative resource use and quality of life | ICU, HDU and hospital length of stay will be determined by the assessment of care level.
Resource use will be costed using credible nationally published sources. Postdischarge resource assessed using a Health Resource Use Questionnaire at 6 weeks and 3 months postsurgery.
Quality-adjusted life years assessed using the EuroQol EQ-5D39 questionnaire at baseline and at 6 weeks and 3 months postsurgery. |
| Compliance with the washing protocol | Data will be collected for all patients during surgery to characterise compliance with the randomly assigned washing protocol. |
| Additional markers of inflammation and organ injury will be assessed in a mechanism substudy in the first 60 consecutive patients recruited at Glenfield Hospital |
▸ Urinary LFABP, NGAL at baseline and at 6, 12 and 24 h.40 41 ▸ Serum troponin I at baseline and at 24 and 48 h. ▸ Platelet aggregation (Multiplate) in the first 48 h. ▸ Transfused RBC characteristics (washed and unwashed); ATP levels, 2,3DPG, deformability, osmotic fragility, cytokine levels. ▸ Serum levels of GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-10 and TNF-α at the same time points as for the primary end point. ▸ Platelet and monocyte activation as determined by flow cytometry for a subgroup of patients. ▸ Endothelial injury as determined by quantification of endothelial-derived microparticles by flow cytometry. ▸ Effect of blood harvested from recipients on platelet and monocyte activation within a microfluidics system.
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