{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:39:19Z","timestamp":1787017159927,"version":"build-2736575974"},"reference-count":18,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2021,12,13]],"date-time":"2021-12-13T00:00:00Z","timestamp":1639353600000},"content-version":"unspecified","delay-in-days":12,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"the Five-Year Plan of Third Affiliated Hospital of Sun Yat-sen University","award":["K00006"],"award-info":[{"award-number":["K00006"]}]},{"name":"National major science and technology project for the prevention and treatment of AIDS and viral hepatitis","award":["2018ZX10302204-002-002"],"award-info":[{"award-number":["2018ZX10302204-002-002"]}]},{"DOI":"10.13039\/501100001809","name":"Natural Science Foundation of China","doi-asserted-by":"crossref","award":["81873572"],"award-info":[{"award-number":["81873572"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100001809","name":"Natural Science Foundation of China","doi-asserted-by":"crossref","award":["82070611"],"award-info":[{"award-number":["82070611"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,11,22]]},"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A total of 200 patients with HBV related ACLF in the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou Eighth People\u2019s Hospital, Nanfang Hospital of Southern Medical University, The Third People\u2019s 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT04597164\">NCT04597164<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-047690","type":"journal-article","created":{"date-parts":[[2021,12,14]],"date-time":"2021-12-14T11:38:56Z","timestamp":1639481936000},"page":"e047690","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":11,"title":["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"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct04597164","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0671-697X","authenticated-orcid":false,"given":"Wenxiong","family":"Xu","sequence":"first","affiliation":[{"name":"Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yangmei","family":"Li","sequence":"additional","affiliation":[{"name":"Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lu","family":"Wang","sequence":"additional","affiliation":[{"name":"Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongbo","family":"Gao","sequence":"additional","affiliation":[{"name":"Guangzhou Eighth People\"s Hospital, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1788-6093","authenticated-orcid":false,"given":"Jinjun","family":"Chen","sequence":"additional","affiliation":[{"name":"Southern Medical University Nanfang Hospital, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Yuan","sequence":"additional","affiliation":[{"name":"The Third People\"s Hospital of Shenzhen, Shenzhen, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6437-615X","authenticated-orcid":false,"given":"Yi","family":"Ouyang","sequence":"additional","affiliation":[{"name":"Xiangya Hospital Central South University, Changsha, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yufeng","family":"Gao","sequence":"additional","affiliation":[{"name":"First Affiliated Hospital of Anhui Medical University, Hefei, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianguo","family":"Li","sequence":"additional","affiliation":[{"name":"Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuejun","family":"Li","sequence":"additional","affiliation":[{"name":"Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6184-5750","authenticated-orcid":false,"given":"Liang","family":"Peng","sequence":"additional","affiliation":[{"name":"Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,12,14]]},"reference":[{"key":"2025121601205667000_11.12.e047690.1","unstructured":"World Health Organization . 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