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Very Low-volume Plasma Exchange in ACLF
Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
840
Start Date
2026-10-01
Completion Date
2028-12-05
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
Double Plasma Molecular Adsorption System (DPMAS)
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.
Low-volume plasma exchange
Three session of plasma exchange with 1000 mL fresh frozen plasma is performed immediately after DPMAS.
Prothrombin Complex Concentrate (PCC)
Prothrombin complex concentrate (300-400 IU) is administered as an intravenous infusion immediately after completion of the artificial liver support system.
Standard Medical Therapy
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.
Very low-volume plasma exchange
Three sessions of plasma exchange with 400 mL fresh frozen plasma is performed immediately after DPMAS.