Efficacy and Economic Evaluation of Nonbiological Artificial Liver Therapy in Acute-on-chronic Hepatitis B Liver Failure.

Not Applicable

Completed

• Conditions: Chronic-on-acute Liver Failure
• Interventions: Other: KM-8800 plasma exchange device (Kuraray, Tokyo, Japan)

• Registration Number: NCT05392673
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

This was a non-blinded, prospective clinical study. From June 2020 to October 2021, 254 patients with HBV-ACLF were treated at the Department of Infectious Diseases, Xiangya Hospital, Central South University (Changsha, China). 186 patients who met the enrollment criteria were included in this study. Inclusion criteria were as follows: (1) aged 18-65 years old; (2) patients with ACLF caused by HBV infection; (3) meeting the diagnostic criteria for ACLF by the Asian Pacific Association for the Study of Liver (APASL).The exclusion criteria were as follows: (1) pregnancy or lactation; (2) previous liver transplantation; (3) hepatocellular carcinoma or other malignancy; (4) human immunodeficiency virus(HIV) infection or other immunocompromised states; (5) complicated with underlying diseases such as severe heart, respiratory, and blood system diseases. Based on the inclusion and exclusion criteria, the investigators randomly matched patients at a 1:1:1 ratio to three groups whose age, sex ratio, complication, and liver function were comparable: comprehensive medical treatment (Control group), PE group, and DPMAS plus half-dose sequential PE (DPMAS + PE group). As a result, 62 subjects per group were recruited into the study. This study was approved by the Clinical Research Ethics Committee of Xiangya Hospital, Central South University with informed content obtained from all participants (No. 202201022). The study protocol followed the principles of the Helsinki Declaration strictly.

All the 186 patients enrolled received comprehensive medical treatment after admission to the hospital, including anti-viral treatment, general supportive treatment, supplementation of blood products, such as albumin and plasma, and symptomatic treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2022-03
• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-24
• Last Update Submitted: 2022-05-24
• Study First Posted: 2022-05-26
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• aged 18-65 years old
• patients with ACLF caused by HBV infection
• meeting the diagnostic criteria for ACLF by the Asian Pacific Association for the Study of Liver.

Exclusion Criteria

• pregnancy or lactation
• previous liver transplantation
• hepatocellular carcinoma or other malignancy
• human immunodeficiency virus(HIV) infection or other immunocompromised state
• complicated with underlying diseases such as severe heart, respiratory, and blood system diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PE(plasma exchange)	KM-8800 plasma exchange device (Kuraray, Tokyo, Japan)	In addition to comprehensive medical treatment, the PE groups were treated with PE or PE plus half-dose sequential PE. In the current study, PE was carried out using the KM-8800 plasma exchange device (Kuraray, Tokyo, Japan). The device was pre-flushed with 2000 mL of normal saline and 20 U/mL heparin dilution. And the blood pump speed was 100 to 120 mL/min and the plasma exchange speed was 25 to 30 mL/min. Before PE, calcium gluconate and diphenhydramine were routinely administrated to prevent an allergic reaction. For each time of plasma exchange,2800 mL fresh frozen plasma was administrated.
DPMAS+half-dose sequential PE	KM-8800 plasma exchange device (Kuraray, Tokyo, Japan)	DPMAS with half-dose sequential PE was applied using the EC-40W plasma separator (Asahi Kasei Medical, Tokyo, Japan), BS330 bilirubin adsorption column (Jianfan Biotechnology, Zhuhai, China), and the neutral microporous adsorption resin HA330-Ⅱ (Jianfan Biotechnology). After the bilirubin adsorption and hemoperfusion treatment, sequential half-dose PE treatment begins. 1400 mL plasma replacement was conducted each time.
comprehensive medical treatment	KM-8800 plasma exchange device (Kuraray, Tokyo, Japan)	All the 62 patients enrolled received comprehensive medical treatment after admission to the hospital, including anti-viral treatment, general supportive treatment, supplementation of blood products, such as albumin and plasma, and symptomatic treatment.

Primary Outcome Measures

Name	Time	Method
Number of Participants with death	90 days
Number of Participants with Liver transplantation	90 days
Number of Participants with survival without liver transplantation	90 days

Secondary Outcome Measures

Name	Time	Method
Progress of biochemical indexes	90 days	elevated bilirubin and transaminase

Trial Locations

Locations (1)

Xiangya Hospital of Central South University; 🇨🇳 Changsha, China