Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Fulminant Hepatic Failure (FHF)

Exclusion Criteria

• •1. Cerebral Perfusion Pressure 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):
• •1. Patients \> 18 yrs of age with Cerebral Perfusion Pressures (CPP) ≤40 mm Hg for one hour or longer.
• •2. Patients ≤18 yrs with CPP ≤35 mm Hg for one hour or longer.
• •2. Chronic liver disease;
• •3. Concomitant disease including chronic congestive heart failure, vascular disease, emphysema, AIDS, cancer, acute fatty-liver disease, hepatitis due to herpes virus, Wilson's disease, or Budd-Chiari syndrome;
• •4. Portal hypertension (e.g., variceal bleed, caput Medusae, and clinically obvious ascites);
• •5. Liver dysfunction due to trauma;
• •6. Hemorrhage or irreversible brain death ( i.e. blood flow studies positive for herniation and/or pupillary reflex absent);
• •7. Platelet count \<50,000/mm3 or reducing to \<80,000/mm3 over a 72 hr. period. (NOTE: Patient may be included at the physician's discretion if platelet count exceeds 50,000mm3 at time of initiation of therapy and can be managed through the administration of blood products);
• •8. Mean Arterial Pressures (MAP) ≤50 mm Hg for one hour or longer as measured by an indwelling arterial line, OR; patients ≤18 years old and whose MAP is ≤40 mm Hg for one hour or longer;
• •9. Vasopressor support exceeding 1.0 µg/kg/min of an alpha-adrenergic agent for one hour or longer;
• •10. Clinical or radiographic evidence of stroke or intracerebral bleeding;
• •11. Seizures uncontrolled by medication;
• •12. Acute myocardial infarction based on clinical and/or electrocardiographic evidence;
• •13. Lung disease defined by a PaO2 ≤ 60mm Hg or an FiO2 ≥0.6, not corrected by medical management (including CVVH if indicated);
• •14. Pregnancy as determined by βhCG results;
• •15. ≤2 weeks postpartum;
• •16. Participation in another investigational study within 30 days of enrollment;
• •17. Prior ELAD® therapy.