Acute on Chronic Liver Failure (ACLF)VLPE-ACLFNCT07857434
Very Low-volume Plasma Exchange in ACLF
A study testing Double Plasma Molecular Adsorption System (DPMAS), Low-volume plasma exchange and Prothrombin Complex Concentrate (PCC) in people with Acute on Chronic Liver Failure (ACLF), run by Third Affiliated Hospital, Sun Yat-Sen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute on Chronic Liver Failure (ACLF)
- What is being tested?
- Double Plasma Molecular Adsorption System (DPMAS), Low-volume plasma exchange and Prothrombin Complex Concentrate (PCC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 5 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years, inclusive.
- 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/dL (≥ 205.2 μmol/L) and international normalized ratio (INR) ≥ 1.5.
- COSSH-ACLF grade 1 or 2.
Who cannot join
- Patients with malignant tumors.
- Pregnant or lactating women.
- Patients co-infected with HIV or other immunodeficiency diseases.
- Patients with unstable cerebral or cardiovascular infarction, or history of organ transplantation.
- 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.
- Platelet count < 50 × 10⁹/L, severe coagulation disorders, or active bleeding.
- History of allergic reactions to extracorporeal circulation, hemoperfusion, or other related materials, or other severe allergies.
- Any other conditions that, in the investigator's judgment, make the patient unsuitable for enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
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/MELD/CLIF-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.
- Conditions
- Acute on Chronic Liver Failure (ACLF)
- Being tested
- Double Plasma Molecular Adsorption System (DPMAS), Low-volume plasma exchange, Prothrombin Complex Concentrate (PCC), Standard Medical Therapy, Very low-volume plasma exchange
- Keywords
- acute on chronic liver failure, artificial liver support system
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Plasma Molecular Adsorption System (DPMAS)Other
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 exchangeOther
Three session of plasma exchange with 1000 mL fresh frozen plasma is performed immediately after DPMAS.
Prothrombin Complex Concentrate (PCC)Drug
Prothrombin complex concentrate (300-400 IU) is administered as an intravenous infusion immediately after completion of the artificial liver support system.
Standard Medical TherapyOther
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 exchangeOther
Three sessions of plasma exchange with 400 mL fresh frozen plasma is performed immediately after DPMAS.
| Study group | Role | What they receive |
|---|---|---|
| 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/ femoral vein catheterization, with heparin or nafamostat used as anticoagulation. Receives: Other: Double Plasma Molecular Adsorption System (DPMAS); Other: Low-volume plasma exchange; Other: Standard Medical Therapy |
| 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/ femoral vein catheterization, with heparin or nafamostat used as anticoagulation. Receives: Other: Double Plasma Molecular Adsorption System (DPMAS); Drug: Prothrombin Complex Concentrate (PCC); Other: Standard Medical Therapy; Other: Very low-volume plasma exchange |
| Plasma-Free DPMAS with Prothrombin Complex Concentrate | Experimental | 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. Receives: Other: Double Plasma Molecular Adsorption System (DPMAS); Drug: Prothrombin Complex Concentrate (PCC); Other: Standard Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28 post-enrollment (± 3 days)
Secondary outcomes (4)
90-Day Non-Liver-Transplant Mortality
The proportion of participants who die from any cause without liver transplantation within 90 days from enrollment.
Measured: 90 days after enrollment
90-Day Bridging to Liver Transplantation Rate
The proportion of participants who undergo liver transplantation within 90 days from enrollment.
Measured: 90 days after enrollment
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/L) + 1.649 × ln (PT-INR) + 0.576 × ln (serum BUN) (mmol/L) + 0.425 × ln (neutrophil) (10E9/L) + 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/dL) + 11.20 × ln (PT-INR) + 9.57 × ln (serum creatinine) (mg/dL) + 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/L) - 2) ). Higher score means a worse outcome.
Measured: Baseline (Day -2 to 0) to Day 14 post-enrollment (± 3 days)
Total Plasma Volume Used During Hospitalization
Cumulative total volume of fresh frozen plasma (mL) used from enrollment to discharge, extracted from medical records.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion5 Nov 2028 (estimated)
- Study completion5 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute on Chronic Liver Failure (ACLF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857434
- Sponsor's protocol ID
- PL22
- Other IDs
- 2025ZD01906500
- Acronym
- VLPE-ACLF
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33462764Saliba 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.
PubMed 36066598Fernandez 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.
PubMed 28847867
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07857434
- Acronym / sponsor ID
- VLPE-ACLF / PL22
- Conditions
- Acute on Chronic Liver Failure (ACLF)
- Keywords
- acute on chronic liver failure, artificial liver support system
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 5 Nov 2028 (estimated)
- Study completion
- 5 Dec 2028 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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/MELD/CLIF-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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Low-Volume Plasma Exchange (Control Group) | Active comparator | Other: Double Plasma Molecular Adsorption System (DPMAS), Other: Low-volume plasma exchange, Other: Standard Medical TherapyParticipants 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. |
| Very Low-volume Plasma Exchange with Prothrombin Complex Concentrate | Experimental | Other: Double Plasma Molecular Adsorption System (DPMAS), Drug: Prothrombin Complex Concentrate (PCC), Other: Standard Medical Therapy, Other: Very low-volume plasma exchangeParticipants 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. |
| Plasma-Free DPMAS with Prothrombin Complex Concentrate | Experimental | Other: Double Plasma Molecular Adsorption System (DPMAS), Drug: Prothrombin Complex Concentrate (PCC), Other: Standard Medical TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years, inclusive.
- 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/dL (≥ 205.2 μmol/L) and international normalized ratio (INR) ≥ 1.5.
- COSSH-ACLF grade 1 or 2.
Key exclusion criteria (8 listed)
- Patients with malignant tumors.
- Pregnant or lactating women.
- Patients co-infected with HIV or other immunodeficiency diseases.
- Patients with unstable cerebral or cardiovascular infarction, or history of organ transplantation.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Plasma-Free DPMAS with Prothrombin Complex Concentrate, Standard Low-Volume Plasma Exchange (Control Group), Very Low-volume Plasma Exchange with Prothrombin Complex Concentrate |
| Low-volume plasma exchangeThree session of plasma exchange with 1000 mL fresh frozen plasma is performed immediately after DPMAS. | Other | Standard Low-Volume Plasma Exchange (Control Group) |
| 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. | Drug | Plasma-Free DPMAS with Prothrombin Complex Concentrate, Very Low-volume Plasma Exchange with Prothrombin Complex Concentrate |
| Standard Medical TherapyAll 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. | Other | Plasma-Free DPMAS with Prothrombin Complex Concentrate, Standard Low-Volume Plasma Exchange (Control Group), Very Low-volume Plasma Exchange with Prothrombin Complex Concentrate |
| Very low-volume plasma exchangeThree sessions of plasma exchange with 400 mL fresh frozen plasma is performed immediately after DPMAS. | Other | Very Low-volume Plasma Exchange with Prothrombin Complex Concentrate |
Primary outcome
28-Day Non-Liver-Transplant Mortality
Time frame: Day 28 post-enrollment (± 3 days)
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.
4 secondary outcomes
90-Day Non-Liver-Transplant Mortality
Time frame: 90 days after enrollment
90-Day Bridging to Liver Transplantation Rate
Time frame: 90 days after enrollment
Change in Prognostic Scores (COSSH-ACLF Ⅱ, MELD, CLIF-C ACLFs) from Baseline at 2 Weeks
Time frame: Baseline (Day -2 to 0) to Day 14 post-enrollment (± 3 days)
Total Plasma Volume Used During Hospitalization
Time frame: Through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Results publication: PubMed 33462764Ocskay 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.
- Results publication: PubMed 36066598Saliba 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.
- Results publication: PubMed 28847867Fernandez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Double Plasma Molecular Adsorption System (DPMAS), Low-volume plasma exchange and Prothrombin Complex Concentrate (PCC) in people with Acute on Chronic Liver Failure (ACLF), run by Third Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Peng, M.D. (13533978874, pliang@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-Day Non-Liver-Transplant Mortality (time frame: Day 28 post-enrollment (± 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07857434, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.