SBIR-STTR Award

Acute Kidney Injury (AKI) commonly occurs in critically ill patients in the ICU. Patients with severe AKI often require continuous renal replacement therapy (CRRT) because it enables hemodynamic stability and better volume control. Anticoagulation therapy is frequently used to keep the CRRT circuit (especially the blood filter) from clotting as many critically ill patients are prothrombotic, and/or when CRRT is commonly performed for multiple days. However both systemic heparin and regional citrate anticoagulation therapy are associated with higher costs, increased circuit complexity, and complications. Consequently a blood filter that operates clot free with little to no anticoagulation for extended periods will eliminate the costs, complexity, and complications of administering anticoagulation therapy, reduce blood loss, reduce the cost of CRRT due to filter clotting and replacement, and reduce the risk of not delivering an adequate dialytic dose to the critically ill AKI patient. We propose to develop an anticoagulant-free blood filter for extended extracorporeal applications using ultra-high- flux and blood compatible silicon nanopore membranes. In the Phase I SBIR project, we will characterize membrane clearance characteristics and optimize the blood flow path of the filter.

Public Health Relevance Statement:
Project Narrative Over 100,000 Acute Kidney Injury (AKI) patients receive renal replacement therapy in the US each year. We are developing a new blood filter with that will operate for multiple days without anticoagulation. The use of the new blood filter will improve AKI patient outcomes while reducing the complexity, costs, and complications.

Project Terms:
Acute Renal Failure with Renal Papillary Necrosis; Albumins; Animals; Anticoagulants; Anticoagulation; Area; base; biomaterial compatibility; Blood; blood filter; Blood flow; C-reactive protein; Characteristics; Citrates; Clinical; Coagulation Process; Complex; cost; Critical Illness; design; Dose; Drops; Family suidae; Fiber; Film; Geometry; Haptoglobins; Hemodialysis; hemodynamics; Hemorrhage; Heparin; heparin-induced thrombocytopenia ; hypoperfusion; Implant; improved; In Vitro; in vivo; Intensive Care Units; Interleukin-6; Kidney; lactate dehydrogenase 3; Liquid substance; Membrane; Modeling; nanopore; Operative Surgical Procedures; Patient-Focused Outcomes; Patients; Performance; Phase; Polymers; pressure; prototype; Renal Replacement Therapy; Risk; Sepsis; shear stress; Silicon; Small Business Innovation Research Grant; Surface; Technology; Therapeutic; Thinness; Toxin; Urea; Venous

Acute Kidney Injury (AKI) commonly occurs in critically ill patients in the ICU. Patients with severe AKI oftenrequire continuous renal replacement therapy (CRRT) because it enables hemodynamic stability and bettervolume control. Anticoagulation therapy is frequently used to keep the CRRT circuit (especially the blood filter)from clotting as many critically ill patients are prothrombotic, and/or when CRRT is commonly performed formultiple days. However, both systemic heparin and regional citrate anticoagulation therapy are associated withhigher costs, increased circuit complexity, and complications. Consequently, we propose to develop ananticoagulant-free blood filter (the HemoCartridge) based on the ultra-high-flux and blood compatible siliconnanopore membrane (SNM) technology for extended extracorporeal applications. The HemoCartridge willoperate clot free with little to no anticoagulation for the length of a CRRT session to eliminate the costs,complexity, and complications of administering anticoagulation therapy, reduce blood loss, reduce the cost ofCRRT due to filter clotting and replacement, and reduce the risk of not delivering an adequate dialytic dose tothe critically ill AKI patient. In this SBIR Phase II proposal, we will develop a clinical-scale HemoCartridge andthen assess uremic toxin clearance and hemocompatibility on the bench top and in the anephric porcinemodel.

Public Health Relevance Statement:
Project Narrative Over 100,000 Acute Kidney Injury (AKI) patients receive continuous renal replacement therapy in the US each year. We are developing a new blood filter with that will operate for at least seven days without anticoagulation. The use of the new blood filter will improve AKI patient outcomes while reducing the complexity, costs, and complications associated with continuous renal replacement therapy with anticoagulation therapy.

Project Terms: