Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF

Study Overview
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Brief Summary
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This study is to investigate investigate the safety and efficacy of Double plasma molecular adsorption system with sequential low-dose plasma exchange in treating hepatitis B virus-related acute-on-chronic liver failure.

Detailed Description
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Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. But there still lacks of effective therapies in treatment of HBV related ACLF, except liver transplantation. Non-bioartificial liver support system treatments may be effective due to previous clinical data. Plasma exchange (PE) and double plasma molecular adsorption system (DPMAS) are two common ways in clinical practice. This study is to investigate the clinical efficacy and safety of combination treatment of DPMAS and low volume PE in patients with HBV related ACLF. This study will be completed in 6 medical center. Two hundred patients with HBV related ACLF enrolled in this study are divided into trial group (DPMAS, low volume PE, and comprehensive internal medical treatment) and control group (comprehensive internal medical treatment). Symptoms, signs, laboratory tests results, adverse events, mortality rates are recorded from treatment baseline to 12 weeks.

Official Title
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Double Plasma Molecular Adsorption System With Sequential Low-Dose Plasma Exchange in Patients With Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Prospective Cohort Study

Conditions
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Hepatitis B, Chronic, Acute-On-Chronic Liver Failure

Intervention / Treatment
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* Other: Artificial liver support system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA > 0.5 year); Age from 18 to 65 years old; Clinical diagnosis of liver failure (serum total bilirubin level > 10 times upper limit of normal; prothrombin time activity < 40% and ≥20%, or prothrombin time international ratio ≤ 2.6 and > 1.5); Platelets > 50*10 E9/L. Exclusion Criteria: Other active liver diseases; Hepatocellular carcinoma or other malignancy; Pregnancy or lactation; Human immunodeficiency virus infection or congenital immune deficiency diseases; Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events; Other important organ dysfunctions or transplantation; Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome; Patients can not follow-up; Investigator considering inappropriate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Artificial liver support system group<br>100 patients in this group will receive treatment of double plasma molecular adsorption system, low volume plasma exchange, and comprehensive internal medical treatment | Other: Artificial liver support system<br>* Patients will receive treatment of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (PE) for three times, and comprehensive internal medical treatment. The volume of plasma adsorption in DPMAS is 5000 6000 millilitre. The volume of fresh frozen plasma used in PE is 1000 millilitre.<br>|
| Comprehensive medical treatment group<br>100 patients in this group will receive comprehensive internal medical treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality or liver transplantation rate | Mortality or liver transplantation rate at 12-week follow-up. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Model for end-stage liver disease (MELD) score variation | Variation of MELD score at 12 weeks after treatment. MELD score = 9.57 × loge(creatinine mg/dl) + 3.78 × loge(TBIL mg/dl) + 11.20 × loge(PT-INR) + 6.43. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis b virus, acute-on-chronic liver failure, double plasma molecular adsorption system, plasma exchange