Use of the ELAD® in Patients With Liver Failure to Provide Expanded Access With Cost Recovery

1. Weight ≥15 kg;
2. Age ≥10 and ≤70 years;
3. MELD score of ≥24;
4. Documented liver failure;
5. Subject or designated representative must be willing to sign an Informed Consent Form specific to this study and comply with study requirements.

Exclusion Criteria:

1. Cerebral Perfusion Pressure (CPP) as measured by an intracranial pressure (ICP) monitor.:

   1. Patients ≥ 18 yrs of age with Cerebral Perfusion Pressures ≤40 mm Hg for one hour or longer.
   2. Patients ≤18 yrs with CPP ≤35 mm Hg for one hour or longer.
2. 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;
3. Portal hypertension;
4. Liver dysfunction due to trauma;
5. Hemorrhage or irreversible brain death;
6. Platelet count \<50,000/mm3 or reducing to \<80,000/mm3 over a 72 hour period;
7. 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;
8. Vasopressor support exceeding 1.0 µg/kg/min of an alpha-adrenergic agent for one hour or longer;
9. Clinical or radiographic evidence of stroke or intracerebral bleeding;
10. Seizures uncontrolled by medication;
11. Acute myocardial infarction based on clinical and/or electrocardiographic evidence;
12. Lung disease defined by a PaO2 ≤ 60mm Hg or an FiO2 ≥0.6;
13. Pregnancy as determined by βhCG results;
14. ≤2 weeks postpartum;
15. Eligible for an open ELAD clinical trial