RecruitingNCT04597164

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

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


Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Enrollment

200 participants

Start Date

Dec 22, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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.

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Interventions

OTHERArtificial liver support system

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.


Locations(1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT04597164


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