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VLPE-ACLF
A Prospective, Multicenter, Open-Label, Non-Inferiority, Randomized Controlled Trial of Non-Bioartificial Liver Support System With Very Low-volume Plasma Exchange in the Treatment of Acute-on-Chronic Liver Failure
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · National Science and Technology Major Project of China
interventional
840
0 countries
N/A
Study Start
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 5, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 5, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a prospective, multicenter, open-label, non-inferiority, randomized controlled trial evaluating the efficacy and safety of very low plasma exchange (400 mL plasma + prothrombin complex concentrate) and plasma-free (prothrombin complex concentrate only) artificial liver support systems compared with standard low-volume plasma exchange (1000 mL plasma) in patients with acute-on-chronic liver failure (ACLF). A total of 840 eligible patients (COSSH grade 1-2) will be enrolled from 10 centers across China and randomly assigned in a 1:1:1 ratio to receive three sessions of treatment (every 2-3 days) combined with standard medical therapy. The primary endpoint is 28-day non-liver-transplant mortality, with a non-inferiority margin of 10%. Secondary endpoints include 90-day non-liver-transplant mortality, 90-day bridging to liver transplantation rate, changes in prognostic scores (COSSH-ACLF Ⅱ, MELD, CLIF-C ACLFs) from baseline at 2 weeks, and total plasma volume used during hospitalization. Safety outcomes include adverse events (bleeding, coagulation disorders, thrombosis, hypotension, infections, allergic reactions). The study aims to establish a plasma-sparing treatment strategy that reduces dependence on blood products while maintaining non-inferior efficacy. The trial is funded by the National Science and Technology Major Project of China and approved by the Medical Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University (Approval No.: 中大附三医伦RG2026-044-01; Approval Date: April 29, 2026). Enrollment is planned from May 2026 to October 2027, with follow-up completed by October 2028. Written informed consent will be obtained from all participants.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 5, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 21, 2026
Actual (reported)October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 5, 2026
Actual (reported)November 5, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 5, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
28-Day Non-Liver-Transplant Mortality
The proportion of participants who die from any cause without liver transplantation within 28 days from enrollment. Survival status is assessed via inpatient monitor of telephone follow-up or outpatient visit.
Day 28 post-enrollment (± 3 days)
90-Day Non-Liver-Transplant Mortality
90 days after enrollment
90-Day Bridging to Liver Transplantation Rate
90 days after enrollment
Change in Prognostic Scores (COSSH-ACLF Ⅱ, MELD, CLIF-C ACLFs) from Baseline at 2 Weeks
Baseline (Day -2 to 0) to Day 14 post-enrollment (± 3 days)
Total Plasma Volume Used During Hospitalization
Through study completion, an average of 3 months
Participants receive standard medical therapy plus three sessions of dual plasma molecular adsorption system (DPMAS) sequential low-volume plasma exchange (LPE) at intervals of 2-3 days. Each session consists of DPMAS (adsorption volume: 5000 mL, duration: 2-3 hours) followed by plasma exchange with 1000 mL of fresh frozen plasma. Vascular access is established via jugular/ femoral vein catheterization, with heparin or nafamostat used as anticoagulation.
Participants receive standard medical therapy plus three sessions of dual plasma molecular adsorption system (DPMAS) sequential very low-volume plasma exchange (400 mL) combined with prothrombin complex concentrate (PCC) at intervals of 2-3 days. Each session consists of DPMAS (adsorption volume: 5000 mL, duration: 2-3 hours) followed by plasma exchange with 400 mL of fresh frozen plasma, and immediately thereafter an intravenous infusion of 300-400 IU of prothrombin complex concentrate. Vascular access is established via jugular/ femoral vein catheterization, with heparin or nafamostat used as anticoagulation.
DPMAS is performed using a hemoperfusion cartridge (HA330-II, Jafron, Zhuhai) and a plasma bilirubin adsorption column (BS330, Jafron, Zhuhai). Each session has an adsorption volume of 5000 mL with a duration of 2-3 hours. The procedure is performed via jugular or femoral vein catheterization, with heparin or nafamostat used for anticoagulation. All three arms receive DPMAS as the core artificial liver support treatment.
Ocskay K, Kanjo A, Gede N, Szakacs Z, Par G, Eross B, Stange J, Mitzner S, Hegyi P, Molnar Z. Uncertainty in the impact of liver support systems in acute-on-chronic liver failure: a systematic review and network meta-analysis. Ann Intensive Care. 2021 Jan 18;11(1):10. doi: 10.1186/s13613-020-00795-0.
Saliba F, Banares R, Larsen FS, Wilmer A, Pares A, Mitzner S, Stange J, Fuhrmann V, Gilg S, Hassanein T, Samuel D, Torner J, Jaber S. Artificial liver support in patients with liver failure: a modified DELPHI consensus of international experts. Intensive Care Med. 2022 Oct;48(10):1352-1367. doi: 10.1007/s00134-022-06802-1. Epub 2022 Sep 6.
First Submitted
September 21, 2026
First Posted
October 5, 2026
Study Start
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 5, 2028
Participants receive standard medical therapy plus three sessions of dual plasma molecular adsorption system (DPMAS) combined with prothrombin complex concentrate (PCC) at intervals of 2-3 days, without any plasma exchange. Each session consists of DPMAS (adsorption volume: 5000 mL, duration: 2-3 hours) followed immediately by an intravenous infusion of 300-400 IU of prothrombin complex concentrate. Vascular access is established via jugular/ femoral vein catheterization, with heparin or nafamostat used as anticoagulation.
Three session of plasma exchange with 1000 mL fresh frozen plasma is performed immediately after DPMAS.
Prothrombin complex concentrate (300-400 IU) is administered as an intravenous infusion immediately after completion of the artificial liver support system.
All participants receive standard medical therapy for acute-on-chronic liver failure per the Chinese Guidelines for the Diagnosis and Treatment of Liver Failure (2024), including antiviral therapy (for HBV/HCV), anti-infective treatment, nutritional support, symptomatic treatment, and prevention/management of complications.
Three sessions of plasma exchange with 400 mL fresh frozen plasma is performed immediately after DPMAS.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Fernandez J, Acevedo J, Wiest R, Gustot T, Amoros A, Deulofeu C, Reverter E, Martinez J, Saliba F, Jalan R, Welzel T, Pavesi M, Hernandez-Tejero M, Gines P, Arroyo V; European Foundation for the Study of Chronic Liver Failure. Bacterial and fungal infections in acute-on-chronic liver failure: prevalence, characteristics and impact on prognosis. Gut. 2018 Oct;67(10):1870-1880. doi: 10.1136/gutjnl-2017-314240. Epub 2017 Aug 28.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 5, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 5, 2026
Record last verified: 2026-10
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