GARNET™ Filter (GARNET Device) IDE Used in Chronic Hemodialysis Patients With a Bloodstream Infection

Exclusion Criteria

• •1. Pregnancy confirmed by positive urine or serum test, or lactating mothers
• •2. Subject with severe concomitant disease expected to prolong hospitalization or cause death in ≤ 30 days, or terminal illness, or "do not resuscitate" code status
• •3. Known sensitivity/allergy to heparin
• •4. Known sensitivity/allergy to polyethersulfone dialyzers
• •5. Active bleeding (e.g. active GI bleeding, hematuria or epistaxis, untreated coagulopathy or bleeding from a non-compressible site)
• •6. Severe thrombocytopenia (platelet count \< 50,000/μL)
• •7. Active enrollment in another study (patients enrolled in an observational study without any interventions or in post-market surveillance do not need to be excluded)
• •8. Inability to achieve vascular access blood flow rates of ≥250mL/min during the previous dialysis treatment
• •9. Requirement for Continuous Renal Replacement Therapy/Sustained Low Efficiency Dialysis (CRRT/SLED) due to hemodynamic instability
• •10. Hemodynamic instability
• •11. Medical conditions requiring regular blood transfusion
• •12. Hypocalcemia or clinical symptoms of hypocalcemia at time of enrollment
• •13. History of or known hypercoagulable state (e.g. Systemic Lupus Erythematosus (SLE), antiphospholipid syndrome/lupus anticoagulant, protein C or S deficiency, antithrombin deficiency, factor V Leiden deficiency, active cancer, sickle cell disease, and history of deep vein thrombosis (DVT))
• •14. History of a condition documented in the medical record within 6 months prior to enrollment that may result in an increased risk for thrombosis, including any of the following:
• •1. Multiple incidents (≥ 2) of unresolvable thrombosis-induced catheter malfunctions which required catheter exchange, occurring within the 6 months prior to enrollment
• •2. Prior history of renal transplant thrombosis
• •3. Elevated Factor VIII with or without familial hypercholesterolemia
• •4. Hyperhomocysteinemia with a homocysteine level of \>4 mg/L (17.2 μmol/L)
• •15. Currently taking oral contraception