NCT04597164

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Artificial 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.

Timeline

• Start date: 2020-12-22
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-10-22
• Last updated: 2024-11-29

Locations

1 site across 1 country: China