Prolonged Extracorporeal Membrane Oxygenation Without Systemic Anticoagulation in Sheep

PURPOSE: Clinically significant bleeding is a common complication of extracorporeal membrane oxygenation (ECMO), with bleeding observed in upwards of 40% of patients. Bleeding is strongly associated with systemic anticoagulation, which is typically necessary to reduce the incidence of thrombosis in the extracorporeal circuit. The InFlo MOBYBOX integrates a multimodal strategy for coagulation mitigation, combining optimized circuit components (pump, oxygenator) design with a biopassive hydrophilic surface coating to address both flow-related and surface-mediated contributors to thrombosis and hemolysis. This study investigated whether such a design could reduce thrombotic burden under conditions typically associated with high coagulation risk, low blood flow rates, thereby potentially reducing reliance on systemic anticoagulation. METHODS: We conducted a seven-day ovine study (n = 4) with InFlo MOBYBOX ECMO systems coated tip-to-tip with a biopassive hydrophilic coating under continuous low-flow conditions (1.8-2.2 L/min) without systemic anticoagulants. ECMO oxygen delivery and carbon dioxide removal were measured across the duration of the run, and clotting, hematology, and organ damage were observed at the end of therapy. RESULTS: The InFlo MOBYBOX exhibited 2.3 ± 3.1% clot coverage localized to the inlet helical pathway, with no device degradation, systemic thrombosis, or end-organ damage. Hematologic indices remained stable, plasma-free hemoglobin confirmed the absence of hemolysis, and oxygen transfer performance was preserved throughout support. CONCLUSION: These preliminary findings suggest that the InFlo MOBYBOX may enable anticoagulant-free low-flow support with minimal thrombosis, hemolysis, and no organ injury, demonstrating the potential value of a multimodal approach using optimized fluidic pathways and a proprietary biopassive hydrophilic surface coating to advance safer extracorporeal therapies.