[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658985":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":36,"studyPopulation":29,"armGroups":37,"interventions":57,"overallOfficials":29,"centralContacts":79,"locations":29,"responsibleParty":85,"collaborators":29,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":29,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":112,"whyStopped":29,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":29},{"fullName":5,"class":6},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"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)",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"90-Day Non-Liver-Transplant Mortality","The proportion of participants who die from any cause without liver transplantation within 90 days from enrollment.","90 days after enrollment",{"measure":19,"description":20,"timeFrame":17},"90-Day Bridging to Liver Transplantation Rate","The proportion of participants who undergo liver transplantation within 90 days from enrollment.",{"measure":22,"description":23,"timeFrame":24},"Change in Prognostic Scores (COSSH-ACLF Ⅱ, MELD, CLIF-C ACLFs) from Baseline at 2 Weeks","Changes in three validated acute-on-chronic liver failure (ACLF) prognostic scoring systems at 2 weeks relative to baseline: Chinese Group on the Study of Severe Hepatitis B (COSSH)-ACLF Ⅱ (COSSH-ACLF Ⅱscore = 0.033 × age + 0.396 × ln (serum TBIL) (umol\u002FL) + 1.649 × ln (PT-INR) + 0.576 × ln (serum BUN) (mmol\u002FL) + 0.425 × ln (neutrophil) (10E9\u002FL) + 0.457 × HE score (HE grade 0 = 1, grade 1 and 2 = 2, grade 3 and 4 = 3)), model for end-stage liver disease (MELD, MELD score= 3.78 × ln (serum TBIL) (mg\u002FdL) + 11.20 × ln (PT-INR) + 9.57 × ln (serum creatinine) (mg\u002FdL) + 6.43), and Chronic Liver Failure Consortium (CLIF-C) ACLFs (CLIF-C ACLFs score = 10 × (0.33 × CLIF-OFs + 0.04 × Age + 0.63 × ln(WBC)(10E9\u002FL) - 2) ). Higher score means a worse outcome.","Baseline (Day -2 to 0) to Day 14 post-enrollment (± 3 days)",{"measure":26,"description":27,"timeFrame":28},"Total Plasma Volume Used During Hospitalization","Cumulative total volume of fresh frozen plasma (mL) used from enrollment to discharge, extracted from medical records.","Through study completion, an average of 3 months",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE","This prospective, multicenter, open-label, non-inferiority randomized controlled trial aims to evaluate very low plasma (400 mL plasma + PCC) and plasma-free (PCC only) artificial liver support versus standard low-volume plasma exchange (1000 mL) in 840 ACLF patients (COSSH grade 1-2) across 10 Chinese centers. Patients receive three sessions (every 2-3 days) plus standard medical therapy. Primary endpoint: 28-day non-liver-transplant mortality (non-inferiority margin: 10%). Secondary endpoints: 90-day mortality, 90-day bridging to transplant, 2-week prognostic score changes (COSSH-ACLFⅡ\u002FMELD\u002FCLIF-C ACLFs), and total plasma use. Safety: adverse events. Funded by the National Science and Technology Major Project of China. Approved by the Medical Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University (RG2026-044-01, April 29, 2026). Enrollment: May 2026-October 2027. Written informed consent required.",[38,46,53],{"label":39,"type":40,"description":41,"interventionNames":42},"Standard Low-Volume Plasma Exchange (Control Group)","ACTIVE_COMPARATOR","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\u002F femoral vein catheterization, with heparin or nafamostat used as anticoagulation.",[43,44,45],"Other: Double Plasma Molecular Adsorption System (DPMAS)","Other: Low-volume plasma exchange","Other: Standard Medical Therapy",{"label":47,"type":48,"description":49,"interventionNames":50},"Very Low-volume Plasma Exchange with Prothrombin Complex Concentrate","EXPERIMENTAL","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\u002F femoral vein catheterization, with heparin or nafamostat used as anticoagulation.",[43,51,45,52],"Drug: Prothrombin Complex Concentrate (PCC)","Other: Very low-volume plasma exchange",{"label":54,"type":48,"description":55,"interventionNames":56},"Plasma-Free DPMAS with Prothrombin Complex Concentrate","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\u002F femoral vein catheterization, with heparin or nafamostat used as anticoagulation.",[43,51,45],[58,62,66,71,75],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":29},"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.",[54,39,47],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":29},"Low-volume plasma exchange","Three session of plasma exchange with 1000 mL fresh frozen plasma is performed immediately after DPMAS.",[39],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":29},"DRUG","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.",[54,47],{"type":6,"name":72,"description":73,"armGroupLabels":74,"otherNames":29},"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\u002FHCV), anti-infective treatment, nutritional support, symptomatic treatment, and prevention\u002Fmanagement of complications.",[54,39,47],{"type":6,"name":76,"description":77,"armGroupLabels":78,"otherNames":29},"Very low-volume plasma exchange","Three sessions of plasma exchange with 400 mL fresh frozen plasma is performed immediately after DPMAS.",[47],[80],{"name":81,"role":82,"phone":83,"phoneExt":29,"email":84},"Liang Peng, M.D.","CONTACT","13533978874","pliang@mail.sysu.edu.cn",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Liang Peng","Professor","100658985","very-low-volume-plasma-exchange-in-aclf-100658985",false,"NCT07857434","Very Low-volume Plasma Exchange in 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","VLPE-ACLF","Inclusion Criteria:\n\n1. Age between 18 and 65 years, inclusive.\n2. Diagnosed with acute-on-chronic liver failure (ACLF) according to the Chinese Guidelines for the Diagnosis and Treatment of Liver Failure (2024), defined as: chronic liver disease (with or without cirrhosis), total bilirubin (TBil) ≥ 12 mg\u002FdL (≥ 205.2 μmol\u002FL) and international normalized ratio (INR) ≥ 1.5.\n3. COSSH-ACLF grade 1 or 2.\n\nExclusion Criteria:\n\n1. Patients with malignant tumors.\n2. Pregnant or lactating women.\n3. Patients co-infected with HIV or other immunodeficiency diseases.\n4. Patients with unstable cerebral or cardiovascular infarction, or history of organ transplantation.\n5. End-stage organ failure defined as any of the following: (a) end-stage chronic obstructive pulmonary disease, end-stage cor pulmonale, brain death or persistent vegetative state, grade IV hepatic encephalopathy; (b) end-stage renal disease or acute renal failure requiring continuous renal replacement therapy (CRRT); (c) mean arterial blood pressure (MAP) persistently below 65 mmHg despite adequate fluid resuscitation, vasoactive agents, and corticosteroid therapy.\n6. Platelet count \\\u003C 50 × 10⁹\u002FL, severe coagulation disorders, or active bleeding.\n7. History of allergic reactions to extracorporeal circulation, hemoperfusion, or other related materials, or other severe allergies.\n8. Any other conditions that, in the investigator's judgment, make the patient unsuitable for enrollment.","ALL","18 Years","65 Years",{"count":101,"type":102},840,"ESTIMATED","INTERVENTIONAL",[105],"NA","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.",[108],"Acute on Chronic Liver Failure (ACLF)",[110,111],"acute on chronic liver failure","artificial liver support system","NOT_YET_RECRUITING","2026-10-02",{"date":115,"type":116},"2026-10-05","ACTUAL",{"date":118,"type":102},"2026-10-01",{"date":120,"type":102},"2028-12-05",{"name":5,"class":6}]