Safety and Efficacy of the ELAD System (ELAD) to Treat Acute Liver Failure (ALF)

Exclusion Criteria

• •1. Cerebral Perfusion Pressure ≤40 mm Hg for 1 hour or longer as measured by an intracranial pressure (ICP) monitor. (NOTE: In those cases where ICP monitor placement cannot be performed prior to study enrollment, this exclusion criterion will not apply);
• •2. Chronic liver disease (e.g., compensated cirrhosis of any etiology, chronic hepatitis, nonalcoholic steatohepatitis, cholestatic liver disease, or metabolic liver disease) (NOTE: steatosis is not an exclusion criterion);
• •3. Acute clinical symptoms that, in the Investigator's opinion, are likely to result in death within 48 hours of enrollment;
• •4. Evidence of infection unresponsive to antibiotics (e.g. increased tissue involvement relative to initial diagnosis, clinical worsening of symptom) indicated by any of the following:
• •1. Presence of sepsis or septic shock; OR
• •2. Positive blood cultures (bacteremia, fungemia) within 72 hours prior to Enrollment; OR
• •3. Presence of spontaneous bacterial peritonitis during the 2 days prior to Enrollment; OR
• •4. Clinical and radiological signs of pneumonia.
• •5. Concomitant disease including chronic congestive heart failure, severe vascular disease, emphysema, AIDS, cancer (except non-melanoma skin cancer), acute fatty-liver disease, hepatitis due to herpes virus or Budd-Chiari syndrome. (NOTE: in the case of subjects enrolled due to surgery-induced liver failure (SILF) then the original cause for the surgery will not be a criterion for exclusion);
• •6. Portal hypertension;
• •7. Liver dysfunction due to trauma;
• •8. Irreversible brain death;
• •9. Platelet count \< 30,000/mm3 \[NOTE: Subject may be included at the physician's discretion if platelet count exceeds 30,000/mm3 at time of initiation of therapy (even if the value is following platelet transfusion) and can be managed through the administration of blood products\]
• •10. Cardiovascular sepsis-related organ failure assessment score (SOFA score) \>3;
• •11. Stroke or intracranial hemorrhage;
• •12. Seizures uncontrolled by medication;
• •13. Acute myocardial infarction;
• •14. Lung disease defined by a partial pressure of oxygen measurement (PaO2) ≤60 mmHg or a fraction of inspired oxygen (FiO2) ≥0.6, not corrected by medical management \[including continuous venovenous hemofiltration (CVVH) if indicated\] and ventilation with a Positive End Expiratory Pressure (PEEP) of \>8cm H2O;
• •15. Acute Respiratory Distress Syndrome;
• •16. Pregnancy as determined by beta-human chorionic gonadotropin (β-hCG) results;
• •17. ≤ 2 weeks postpartum;
• •18. Participation in another investigational drug, biologic, or device study within one month of enrollment, except for observational studies (the observational study setting should not affect the safety and/or efficacy of the VTI-212 clinical trial);
• •19. Prior ELAD therapy;
• •20. Has a Do Not Resuscitate or a Do Not Intubate (DNR/DNI) directive (or local equivalent) or any other Advanced Directive limiting Standard of Care in place (the DNR/DNI criterion is not applicable in the UK).