PMID- 34907041
OWN - NLM
STAT- MEDLINE
DCOM- 20220222
LR  - 20220222
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 11
IP  - 12
DP  - 2021 Dec 14
TI  - Efficacy and safety of combination treatment of double plasma molecular 
      adsorption system and low volume plasma exchange for patients with hepatitis B 
      virus related acute-on-chronic liver failure: a multicentre randomised controlled 
      clinical trial.
PG  - e047690
LID - 10.1136/bmjopen-2020-047690 [doi]
LID - e047690
AB  - INTRODUCTION: Hepatitis B virus (HBV) related acute-on-chronic liver failure 
      (ACLF) is still a common type of liver failure in China. Therefore, we conduct 
      this multicentre, non-blinded, randomised controlled clinical trial to 
      investigate the efficacy and safety of combination treatment of double plasma 
      molecular adsorption system (DPMAS) and low volume plasma exchange (PE) for 
      patients with HBV related ACLF. METHODS AND ANALYSIS: A total of 200 patients 
      with HBV related ACLF in the Third Affiliated Hospital of Sun Yat-sen University, 
      Guangzhou Eighth People's Hospital, Nanfang Hospital of Southern Medical 
      University, The Third People's Hospital of Shenzhen, Xiangya Hospital of Central 
      South University and The First Affiliated Hospital of Anhui Medical University, 
      will be recruited into this trial. Eligible patients will undergo randomisation 
      at a 1:1 ratio to two arms: the control group and the trial group. Patients in 
      control group will receive comprehensive internal medical treatment. Patients in 
      trial group will receive treatment of DPMAS and sequential low volume PE for 
      three times, and comprehensive internal medical treatment. Clinical safety will 
      be assessed by the analysis of adverse events (AEs) and laboratory tests. The 
      primary efficacy outcome will be the incidence of unfavored events including 
      death, liver transplantation and treatment abandonment. The secondary efficacy 
      outcome will be the model for end-stage liver disease score variation. All 
      evaluations will be performed at baseline, and 4, 8, 12, 24, 36, 48 weeks after 
      enrolment. All AEs will be reported as soon as they are noted during the entire 
      study procedure. ETHICS AND DISSEMINATION: This study was approved by Ethics 
      Committee of the Third Affiliated Hospital of Sun Yat-sen University (approval 
      no. (2020)02-173-01). The results and conclusions of this clinical trial will be 
      published at academic conferences or in journals. TRIAL REGISTRATION NUMBER: 
      NCT04597164.
CI  - (c) Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Xu, Wenxiong
AU  - Xu W
AUID- ORCID: 0000-0002-0671-697X
AD  - Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
FAU - Li, Yangmei
AU  - Li Y
AD  - Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
FAU - Wang, Lu
AU  - Wang L
AD  - Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
FAU - Gao, Hongbo
AU  - Gao H
AD  - Guangzhou Eighth People's Hospital, Guangzhou, China.
FAU - Chen, Jinjun
AU  - Chen J
AUID- ORCID: 0000-0002-1788-6093
AD  - Southern Medical University Nanfang Hospital, Guangzhou, China.
FAU - Yuan, Jing
AU  - Yuan J
AD  - The Third People's Hospital of Shenzhen, Shenzhen, China.
FAU - Ouyang, Yi
AU  - Ouyang Y
AUID- ORCID: 0000-0002-6437-615X
AD  - Xiangya Hospital Central South University, Changsha, China.
FAU - Gao, Yufeng
AU  - Gao Y
AD  - First Affiliated Hospital of Anhui Medical University, Hefei, China.
FAU - Li, Jianguo
AU  - Li J
AD  - Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China 
      pliang@mail.sysu.edu.cn lixuejun@mail.sysu.edu.cn ljiang@mail.sysu.edu.cn.
FAU - Li, Xuejun
AU  - Li X
AD  - Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China 
      pliang@mail.sysu.edu.cn lixuejun@mail.sysu.edu.cn ljiang@mail.sysu.edu.cn.
FAU - Peng, Liang
AU  - Peng L
AUID- ORCID: 0000-0001-6184-5750
AD  - Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China 
      pliang@mail.sysu.edu.cn lixuejun@mail.sysu.edu.cn ljiang@mail.sysu.edu.cn.
LA  - eng
SI  - ClinicalTrials.gov/NCT04597164
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20211214
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - *Acute-On-Chronic Liver Failure/therapy
MH  - Adsorption
MH  - *End Stage Liver Disease/therapy
MH  - Hepatitis B virus
MH  - Humans
MH  - Plasma Exchange
MH  - Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC8671914
OTO - NOTNLM
OT  - clinical trials
OT  - hepatobiliary disease
OT  - hepatology
COIS- Competing interests: None declared.
EDAT- 2021/12/16 06:00
MHDA- 2022/02/23 06:00
PMCR- 2021/12/14
CRDT- 2021/12/15 06:36
PHST- 2021/12/15 06:36 [entrez]
PHST- 2021/12/16 06:00 [pubmed]
PHST- 2022/02/23 06:00 [medline]
PHST- 2021/12/14 00:00 [pmc-release]
AID - bmjopen-2020-047690 [pii]
AID - 10.1136/bmjopen-2020-047690 [doi]
PST - epublish
SO  - BMJ Open. 2021 Dec 14;11(12):e047690. doi: 10.1136/bmjopen-2020-047690.