Status:
NO_LONGER_AVAILABLE
Use of the ELAD® in Patients With Liver Failure to Provide Expanded Access With Cost Recovery
Lead Sponsor:
Vital Therapies, Inc.
Conditions:
Liver Failure
Eligibility:
All Genders
10-70 years
Brief Summary
VTI had established other clinical protocols to study the effects of ELAD® plus standard therapy compared with standard therapy alone in patients with acute on chronic (AOCH) (VTI-201, VTI-206) and fu...
Detailed Description
ELAD® therapy is designed to provide continuous liver support to a subject with compromised liver function, allowing time for the subject's native liver to regenerate to a healthy state, or to stabili...
Eligibility Criteria
Inclusion
- Weight ≥15 kg;
- Age ≥10 and ≤70 years;
- MELD score of ≥24;
- Documented liver failure;
- Subject or designated representative must be willing to sign an Informed Consent Form specific to this study and comply with study requirements.
Exclusion
- Cerebral Perfusion Pressure (CPP) as measured by an intracranial pressure (ICP) monitor.:
- Patients ≥ 18 yrs of age with Cerebral Perfusion Pressures ≤40 mm Hg for one hour or longer.
- Patients ≤18 yrs with CPP ≤35 mm Hg for one hour or longer.
- 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;
- Portal hypertension;
- Liver dysfunction due to trauma;
- Hemorrhage or irreversible brain death;
- Platelet count \<50,000/mm3 or reducing to \<80,000/mm3 over a 72 hour period;
- 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;
- Vasopressor support exceeding 1.0 µg/kg/min of an alpha-adrenergic agent for one hour or longer;
- Clinical or radiographic evidence of stroke or intracerebral bleeding;
- Seizures uncontrolled by medication;
- Acute myocardial infarction based on clinical and/or electrocardiographic evidence;
- Lung disease defined by a PaO2 ≤ 60mm Hg or an FiO2 ≥0.6;
- Pregnancy as determined by βhCG results;
- ≤2 weeks postpartum;
- Eligible for an open ELAD clinical trial
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00832273
Last Update
September 10 2013
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