Objective
Generation of plasma free hemoglobin (pfHb) and activated complement during complex cardiac surgery contributes to end-organ dysfunction. This prospective, multi-center REFRESH I (REduction in FREe Hemoglobin) randomized controlled trial (RCT) evaluated the safety and feasibility of CytoSorb hemoadsorption therapy to reduce these factors during prolonged cardiopulmonary bypass (CPB).
Methods
Eligible patients underwent elective, non-emergent complex cardiac surgery with expected CPB duration ≥ 3h. Exclusions included single procedures including primary CABG, single valves, transplant, and LVAD extraction. TREATMENT used two parallel 300 ml CytoSorb hemoadsorption cartridges in a side circuit during CPB. CONTROL was standard of care.