Multi-center, randomized, controlled and open-label study of ELAD biological artificial liver in the treatment of patients with hepatic dysfunction and failure

INTERVENTION: Group A:Plasma Exchange+Continuous Venous‐venous Hemofiltration;Group B:Plasma Exchange+Continuous Venous‐venous Hemofiltration+ELAD; CONDITION: Hepatic dysfunction and hepatic failure PRIMARY OUTCOME: Survial Time and Survival Rate; SECONDARY OUTCOME: PTA, MELD, CTP, APACHE, SOFA, Bilirubin, Albumin, PA, CHE, INR, APTT, FIB, ammonia, every symptoms, signs, etc.; INCLUSION CRITERIA: 1. Chinese citizen, male or female, age range 15‐66 y (including 15y and 66y); can afford the expense of basic treatments except ELAD; 2. Acute, sub‐acute, acute or chronic (i.e., chronic severe hepatitis) hepatic dysfunction and hepatic failure caused by various reasons; e.g., virus, alcohol, drug or inherited metabolic disease; 3. Obvious gastrointestinal and/or systemic toxic symptoms; 4. TBil>=5XULN, or the daily increase of total bilirubin > 1mg/dL(17.1umol/L; 5. Prothrombin time activity (PTA)> 10% and 50%; or INR> 1.6 and 4.0, or PT >=5 sec. and 20 sec. longer than control; 6. Without hepatoencephalopathy, or encephalopathy below Grade II (including Grade II); 7. Patient or its legal representative could understand and sign the informed consent form, could exchange information with the investigator, could understand and cooperate the implementation of the clinical trial.