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

ConditionsHepatitis B, Chronic Acute-On-Chronic Liver Failure

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-65

SponsorThird Affiliated Hospital, Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Other active liver diseases;

Hepatocellular carcinoma or other malignancy;

Pregnancy or lactation;

Human immunodeficiency virus infection or congenital immune deficiency diseases;

Trial population

This prospective study included patients diagnosed with HBV-ACLF at the Department of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University (Guangdong Province, China).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Artificial liver support system
Other intervention
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.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Artificial liver support system group1 intervention

Group B: Comprehensive medical treatment group0 interventions

Trial outcomes

Primary outcomes

Mortality or liver transplantation rate

Mortality or liver transplantation rate at 12-week follow-up.

Time frame

12 weeks

Secondary outcomes

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.

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Third Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov

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