Acute-On-Chronic Liver Failure, Hepatitis B, Chronic
Conditions
Keywords
hepatitis b virus, acute-on-chronic liver failure, double plasma molecular adsorption system, plasma exchange
Brief summary
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
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.
Interventions
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.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \> 0.5 year); 2. Age from 18 to 65 years old; 3. 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); 4. Platelets \> 50\*10 E9/L.
Exclusion criteria
1. Other active liver diseases; 2. Hepatocellular carcinoma or other malignancy; 3. Pregnancy or lactation; 4. Human immunodeficiency virus infection or congenital immune deficiency diseases; 5. Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events; 6. Other important organ dysfunctions or transplantation; 7. Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome; 8. Patients can not follow-up; 9. Investigator considering inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality or liver transplantation rate | 12 weeks | Mortality or liver transplantation rate at 12-week follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Model for end-stage liver disease (MELD) score variation | 12 weeks | 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. |
Countries
China
Contacts
Primary ContactWenxiong Xu, Doctor
Backup ContactLiang Peng, Doctor
Outcome results
None listed