A prospective study to evaluate the effect of the Molecular Adsorbent Recirculating System (MARS®) for patients with acute liver failure

Completed

Conditions: Acute liver failureAcute on chronic liver failure due to hepatitis B
Injury, Occupational Diseases, Poisoning

Registration Number: ISRCTN40657638

Lead Sponsor: Gambro Korea Ltd (Korea, South)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

1. Acute liver failure patient in accordance with American Association for the Study of Liver Diseases (AASLD) guideline
2. Age between 20 and 70
3. Patient with a sign of hepatic encephalopathy
4. If a patient is able to make decisions on his/her own, a subject?s own consent and signature is required. However, if a patient is unable to make decisions on his/her own due to hepatic coma, a consent and signature by a legal representative is required.
5. All of the above
6. Or acute-on-chronic liver failure (AoCLF) with hepatitis B including No. 2, 3 and 4 above

Exclusion Criteria

1. Acute liver failure due to acetaminophen
2. Acute hepatitis A
3. Patient with a sign of hepatic encephalopathy due to alcoholic hepatitis
4. Patient with anamnesis of chronic liver disease (except hepatitis B)
5. Among autoimmune disease patients with abrupt recurrence, those who display varix and nodularity on CT or duodenoscopy
6. Patient with anamnesis of hepatocirrhosis (except hepatitis B)
7. Septic shock
8. Patient with irreciprocal multiorgan failure
9. Abrupt bleeding
10. Pregnant or lactating women
11. Patient whose mean arterial pressure (MAP) is below 55 mmHg despite usage of hypertensor
12. Coma of non-hepatic origin
13. Uncontrollable sepsis
14. Extrahepatic cholestasis
15. Extrahepatic neoplasia
16. Patient with irreciprocal brain/organ damage leading to transplantation rejection syndrome
17. HIV hepatitis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6-month survival rate (measured 6 months from the enrolled date of this study)

Secondary Outcome Measures

Name	Time	Method
1. In case of no transplantation, one-year survival rate from the date of admittance to the study<br>2. One-year survival rate post-transplantation<br>3. Survival period length pre-transplantation<br>4. An improvement in hepatic encephalopathy (using Glasgow Coma Scale in accordance with Appendix 1); measured every day during hospitalization<br>5. Bilirubin level improvement after MARS treatment; measured at 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months and 6 months using a biochemical test<br>6. Laboratory parameter improvement; measured at 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months and 6 months using a biochemical test