Acute on Chronic Liver Failure (ACLF)PhoenixNCT07593638
Plasma Exchange Half-dose and Extracorporeal Detoxification for ACLF
A study testing DPMAS plus plasma exchange in people with Acute on Chronic Liver Failure (ACLF), run by Unidade Local de Saude do Nordeste at 1 site in Portugal.
Trial summary
Clinical trial The goal of this clinical trial is to learn if a liver support protocol works to treat Liver failure in adults. The main questions it aims to answer are: Does hemoadsorption plus half-dose plasma exchange provide support to liver failure patients until recovery or transplant What medical problems do… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute on Chronic Liver Failure (ACLF)
- What is being tested?
- DPMAS plus plasma exchange
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePortugal
- Study dates
- Jul 2026to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent for participation in the study
- Admission to the ICU with a diagnosis of ACLF of reversible etiology (infection, bleeding, alcohol-related, toxic, etc.)
- Total bilirubin ≥ 12 mg/dL and INR ≥ 1.5
- On the waiting list for liver transplantation or not a candidate for transplantation but with an indication for supportive therapy
Who cannot join
- Refusal to provide consent
- Pregnancy
- Expected survival < 24 hours due to disease severity (hemodynamic instability requiring norepinephrine > 0.20 mcg/kg/min and/or mechanical ventilation with PaO₂/FiO₂ < 150 and/or non-hepatic coma)
- ACLF severity greater than CLIF-C ACLF grade 3
- Advanced organ dysfunction: Pulmonary (GOLD stage 3 or 4) and/or Cardiac (NYHA functional class III or IV)
- Advanced or metastatic oncological disease (life expectancy < 6 months)
- Marked frailty syndrome or secondary sarcopenia
- Participation in another clinical trial within the previous 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Unidade Hospitalar de Bragança
Bragança, Braganza District, 5301-852
Tiago B Loza, Consultant Physician, 913013068 ext. 00351, tiago.loza@ulsne.min-saude.pt
Carla Gomes
About this study
Clinical trial
The goal of this clinical trial is to learn if a liver support protocol works to treat Liver failure in adults. The main questions it aims to answer are:
- Does hemoadsorption plus half-dose plasma exchange provide support to liver failure patients until recovery or transplant
- What medical problems do participants have during the technique? Researchers will compare DPMAS plus half-dose plasma exchange with conventional treatment to evaluate a gain in recovery
Participants will:
- Be submitted to DPMAS plus half dose plasma exchange daily according to protocol.
- Monitoring will be continuous in the ICU
Read the detailed description
Acute-on-chronic liver failure (ACLF) is a complex and life-threatening syndrome that develops when chronic liver disease suddenly decompensates. It is marked by systemic inflammation, the accumulation of albumin-bound toxins, and the rapid onset of multiorgan failure. The main drivers of this process include elevated levels of bilirubin and bile acids, an intense cytokine storm, and a profound loss of the liver's synthetic capacity.
Clinicians classify ACLF into three grades of increasing severity, with 28-day mortality ranging from 20-30% in grade 1, 40-60% in grade 2, and exceeding 70% in grade 3. Despite important advances in understanding its pathophysiology, effective therapeutic options remain limited, particularly for patients who are not candidates for liver transplantation. At present, no widely accepted extracorporeal liver support therapy has proven consistently successful. The central goal of care is therefore to stabilize the patient, control the inflammatory response and toxin burden, and create the conditions for hepatic regeneration or to serve as a bridge to transplantation.
Over the past decades, extracorporeal blood purification techniques have been explored as adjunctive therapies. High-volume plasma exchange has shown potential to reduce inflammatory mediators and improve survival in selected patients with acute liver failure or ACLF. However, its routine use is constrained by high plasma consumption, significant transfusion-related risks, and logistical challenges.
The Double Plasma Molecular Adsorption System (DPMAS), which employs the BS330 adsorber for bilirubin and bile acids and the HA330-2 adsorber for cytokines and inflammatory mediators, offers a more targeted approach. When combined with half-dose plasma exchange and appropriate replacement of plasma components, this hybrid detoxification strategy achieves effective toxin removal and immune modulation while substantially reducing the volume of plasma required. In our intensive care unit, this hybrid protocol has been developed and refined through clinical experience and informed by earlier studies. Several critically ill patients with ACLF who would otherwise have died or required urgent transplantation showed encouraging signs of recovery. Nevertheless, robust evidence from a randomized controlled trial is still needed to confirm the efficacy and safety of this combined approach in patients with ACLF of reversible aetiology.
- Conditions
- Acute on Chronic Liver Failure (ACLF)
- Being tested
- DPMAS plus plasma exchange
- Keywords
- DPMAS, Plasma exchange, ACLF
- 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.
DPMAS plus plasma exchangeDevice
Use of extracorporal technique to support patients with acute on chronic liver failure
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | No intervention | Conventional therapy to ACLF |
| DPMAS plus Plasma exchange | Experimental | Patients in this arm will be submitted to:
DPMAS: selective adsorption therapy; mainly removes bilirrubin and inflammatory mediators AND Half-dose plasma exchange: nonselective plasma removal and replacement by a donor Receives: Device: DPMAS plus plasma exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality or need for liver transplantation
28-day mortality and/or need for liver transplantation
Measured: From enrollment to 28 days after
Secondary outcomes (18)
Total bilirrubin level
Units: mg/dL
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
INR
International Normalized Ratio
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
SOFA
Sequential Organ Failure Assessment Score. Scale: 0-24. Higher score means worst outcome.
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks.
CLIF-C ACLF score
Chronic Liver Failure Consortium Acute-on-Chronic Liver Failure score. Range 0-100
Measured: Measur at day of randomization, 72h after and 7 days after
Mortality or liver transplant at day 90
Mortality or liver transplant at day 90 after randomization
Measured: 90 days after randomization
Encephalopathy
Grade of encephalopathy according West Haven score. Grade 0-4. Higher score means worst outcome.
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Vasopressor free days
Number of days without need of vasopressor support
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Invasive mechanical ventilation free days
Number of days without need of invasive mechanical ventilation
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
CRRT free days
Number of days without need of Continuous Renal Replacement Therapy
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - bleeding events
Bleeding events will be recorded and classified as major bleeding, clinically relevant non-major bleeding or minor bleeding according to standard critical care definitions. Assessment will include overt hemorrhage, intracranial bleeding, gastrointestinal bleeding, procedure-related bleeding, transfusion requirements and decreases in hemoglobin levels.
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Coagulation Abnormalities
Serial coagulation monitoring will include INR, fibrinogen concentration, platelet count and activated clotting parameters when applicable. Development or worsening of coagulopathy during DPMAS or plasma exchange sessions will be documented.
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Hemodynamic Instability
Episodes of hypotension during or after extracorporeal therapy sessions will be recorded, including increases in vasopressor requirements, reduction in mean arterial pressure, arrhythmias or interruption of treatment due to cardiovascular instability.
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Circuit-Related Complications
Extracorporeal circuit complications will include filter clotting, premature circuit failure, interruption of therapy, vascular access dysfunction, catheter thrombosis and technical complications related to DPMAS or plasma exchange delivery
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Metabolic and Electrolyte Disturbance
Metabolic complications including acid-base disturbances, electrolyte abnormalities and clinically significant metabolic derangements occurring during therapy will be recorded
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Hematologic Complications
Development of thrombocytopenia, hemolysis or significant transfusion requirements associated with extracorporeal therapy will be assessed throughout treatment and follow-up.
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Infectious Complications
New infections, catheter-related bloodstream infections, bacteremia and sepsis episodes occurring during treatment or ICU stay will be documented.
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Renal Complications
Renal outcomes will include development or worsening of acute kidney injury, need for renal replacement therapy and renal replacement therapy-free days.
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Neurological Complications
Neurological adverse events including worsening hepatic encephalopathy, seizures, cerebral edema or unexplained neurological deterioration will be monitored and documented.
Measured: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Design: Multicenter, randomized, parallel-group, controlled clinical trial conducted in intensive care units (ICUs) in Portugal and Spain. Recruitment Period: May 2026 - December 2027. Each participating ICU will recruit its own patients. Inclusion Criteria: Age over 18 years, Written informed consent for participation, Admission to the ICU with a diagnosis of ACLF of reversible etiologyic, Total bilirubin ≥ 12 mg/dL and INR ≥ 1.5, On the waiting list for liver transplantation or not a candidate for transplantation but with an indication for supportive therapy Exclusion Criteria: Refusal to provide consent, Pregnancy, Expected survival \< 24 hours due to disease severity (hemodynamic instability requiring norepinephrine \> 0.20 mcg/kg/min and/or mechanical ventilation with PaO₂/FiO₂ \< 150 and/or non-hepatic coma), ACLF severity greater than CLIF-C ACLF grade 3, Advanced organ dysfunction, advanced or metastatic oncological disease, Marked frailty syndrome or second,
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saude do Nordeste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiago Bessa Gradim Loza, Unidade Local de Saude do Nordeste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593638
- Sponsor's protocol ID
- Phoenix
- Acronym
- Phoenix
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available upon reasonable request always with anonymity
Publications
Schonfelder K, Hirsch LK, Kribben A, Jahn M, Tyczynski B, Friebus-Kardash J. Artificial liver support with Cytosorb and continuous veno-venous hemodiafiltration versus advanced organ support (ADVOS) for critically ill patients with hyperbilirubinemia and acute-on-chronic liver failure (ACLF). BMC Nephrol. 2025 Aug 4;26(1):432. doi: 10.1186/s12882-025-04342-6.
PubMed 40759919Toapanta-Gaibor D, Sanchez-Ballesteros J, Gonzalez-Fernandez M, Broch-Porcar MJ. Advances in extracorporeal liver support for acute and acute-on-chronic liver failure. Med Intensiva (Engl Ed). 2025 Nov;49(11):502291. doi: 10.1016/j.medine.2025.502291. Epub 2025 Aug 11.
PubMed 40796412Karkmann K, Piecha F, Runzi AC, Schulz L, von Wulffen M, Benten D, Kluwe J, Wege H. [Management of compensated liver cirrhosis 2018 - Evidence based prophylactic measures]. Z Gastroenterol. 2018 Jan;56(1):55-69. doi: 10.1055/s-0043-124000. Epub 2018 Jan 9. German.
PubMed 29316579Scharf C, Liebchen U, Paal M, Becker-Pennrich A, Irlbeck M, Zoller M, Schroeder I. Successful elimination of bilirubin in critically ill patients with acute liver dysfunction using a cytokine adsorber and albumin dialysis: a pilot study. Sci Rep. 2021 May 13;11(1):10190. doi: 10.1038/s41598-021-89712-4.
PubMed 33986443Double Plasma Molecular Adsorption System as Treatment in A Severe Acute-On-Chronic Liver Failure in A Patient with Autoimmune Hepatitis Author: Mariana Zavala-Gómez, Rodrigo López-Contreras, Daniel Alvarez-Lara, Carlos Cortez-Hernadez, Llia Rizo-Topete https://dx.doi.org/10.47746/FMCR.2025.6104
Xu W, Zhu S, Yang L, Li Z, Wu L, Zhang Y, Chen J, Deng Z, Luo Q, Peng L. Safety and efficacy of double plasma molecular adsorption system with sequential low-volume plasma exchange in intermediate-stage hepatitis B virus-related acute-on-chronic liver failure. J Med Virol. 2023 Mar;95(3):e28650. doi: 10.1002/jmv.28650.
PubMed 36897008Marcello M, Ronco C. Bilirubin Adsorption with DPMAS: Mechanism of Action and Efficacy of Anion Exchange Resin. Contrib Nephrol. 2023;200:201-209. doi: 10.1159/000526729. Epub 2023 Jun 1.
PubMed 37263196
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Exchange Half-dose and Extracorporeal Detoxification for ACLF
- ClinicalTrials.gov ID
- NCT07593638
- Acronym / sponsor ID
- Phoenix / Phoenix
- Conditions
- Acute on Chronic Liver Failure (ACLF)
- Keywords
- DPMAS, Plasma exchange, ACLF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Unidade Local de Saude do NordesteUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 May 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.
Clinical trial
The goal of this clinical trial is to learn if a liver support protocol works to treat Liver failure in adults. The main questions it aims to answer are:
- Does hemoadsorption plus half-dose plasma exchange provide support to liver failure patients until recovery or transplant
- What medical problems do participants have during the technique? Researchers will compare DPMAS plus half-dose plasma exchange with conventional treatment to evaluate a gain in recovery
Participants will:
- Be submitted to DPMAS plus half dose plasma exchange daily according to protocol.
- Monitoring will be continuous in the ICU
Detailed description
Acute-on-chronic liver failure (ACLF) is a complex and life-threatening syndrome that develops when chronic liver disease suddenly decompensates. It is marked by systemic inflammation, the accumulation of albumin-bound toxins, and the rapid onset of multiorgan failure. The main drivers of this process include elevated levels of bilirubin and bile acids, an intense cytokine storm, and a profound loss of the liver's synthetic capacity.
Clinicians classify ACLF into three grades of increasing severity, with 28-day mortality ranging from 20-30% in grade 1, 40-60% in grade 2, and exceeding 70% in grade 3. Despite important advances in understanding its pathophysiology, effective therapeutic options remain limited, particularly for patients who are not candidates for liver transplantation. At present, no widely accepted extracorporeal liver support therapy has proven consistently successful. The central goal of care is therefore to stabilize the patient, control the inflammatory response and toxin burden, and create the conditions for hepatic regeneration or to serve as a bridge to transplantation.
Over the past decades, extracorporeal blood purification techniques have been explored as adjunctive therapies. High-volume plasma exchange has shown potential to reduce inflammatory mediators and improve survival in selected patients with acute liver failure or ACLF. However, its routine use is constrained by high plasma consumption, significant transfusion-related risks, and logistical challenges.
The Double Plasma Molecular Adsorption System (DPMAS), which employs the BS330 adsorber for bilirubin and bile acids and the HA330-2 adsorber for cytokines and inflammatory mediators, offers a more targeted approach. When combined with half-dose plasma exchange and appropriate replacement of plasma components, this hybrid detoxification strategy achieves effective toxin removal and immune modulation while substantially reducing the volume of plasma required. In our intensive care unit, this hybrid protocol has been developed and refined through clinical experience and informed by earlier studies. Several critically ill patients with ACLF who would otherwise have died or required urgent transplantation showed encouraging signs of recovery. Nevertheless, robust evidence from a randomized controlled trial is still needed to confirm the efficacy and safety of this combined approach in patients with ACLF of reversible aetiology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study Design: Multicenter, randomized, parallel-group, controlled clinical trial conducted in intensive care units (ICUs) in Portugal and Spain. Recruitment Period: May 2026 - December 2027. Each participating ICU will recruit its own patients. Inclusion Criteria: Age over 18 years, Written informed consent for participation, Admission to the ICU with a diagnosis of ACLF of reversible etiologyic, Total bilirubin ≥ 12 mg/dL and INR ≥ 1.5, On the waiting list for liver transplantation or not a candidate for transplantation but with an indication for supportive therapy Exclusion Criteria: Refusal to provide consent, Pregnancy, Expected survival < 24 hours due to disease severity (hemodynamic instability requiring norepinephrine > 0.20 mcg/kg/min and/or mechanical ventilation with PaO₂/FiO₂ < 150 and/or non-hepatic coma), ACLF severity greater than CLIF-C ACLF grade 3, Advanced organ dysfunction, advanced or metastatic oncological disease, Marked frailty syndrome or second,
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | No intervention | –Conventional therapy to ACLF |
| DPMAS plus Plasma exchange | Experimental | Device: DPMAS plus plasma exchangePatients in this arm will be submitted to: DPMAS: selective adsorption therapy; mainly removes bilirrubin and inflammatory mediators AND Half-dose plasma exchange: nonselective plasma removal and replacement by a donor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent for participation in the study
- Admission to the ICU with a diagnosis of ACLF of reversible etiology (infection, bleeding, alcohol-related, toxic, etc.)
- Total bilirubin ≥ 12 mg/dL and INR ≥ 1.5
- On the waiting list for liver transplantation or not a candidate for transplantation but with an indication for supportive therapy
Key exclusion criteria (8 listed)
- Refusal to provide consent
- Pregnancy
- Expected survival < 24 hours due to disease severity (hemodynamic instability requiring norepinephrine > 0.20 mcg/kg/min and/or mechanical ventilation with PaO₂/FiO₂ < 150 and/or non-hepatic coma)
- ACLF severity greater than CLIF-C ACLF grade 3
- Advanced organ dysfunction: Pulmonary (GOLD stage 3 or 4) and/or Cardiac (NYHA functional class III or IV)
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 |
|---|---|---|
| DPMAS plus plasma exchangeUse of extracorporal technique to support patients with acute on chronic liver failure | Device | DPMAS plus Plasma exchange |
Primary outcome
Mortality or need for liver transplantation
Time frame: From enrollment to 28 days after
28-day mortality and/or need for liver transplantation
18 secondary outcomes
Total bilirrubin level
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
INR
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
SOFA
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks.
CLIF-C ACLF score
Time frame: Measur at day of randomization, 72h after and 7 days after
Mortality or liver transplant at day 90
Time frame: 90 days after randomization
Encephalopathy
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Vasopressor free days
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Invasive mechanical ventilation free days
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
CRRT free days
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - bleeding events
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Coagulation Abnormalities
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Hemodynamic Instability
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Circuit-Related Complications
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Metabolic and Electrolyte Disturbance
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Hematologic Complications
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Infectious Complications
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Renal Complications
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
Safety issues - Neurological Complications
Time frame: Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks
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 18 May 2026.
- Background: PubMed 40759919Schonfelder K, Hirsch LK, Kribben A, Jahn M, Tyczynski B, Friebus-Kardash J. Artificial liver support with Cytosorb and continuous veno-venous hemodiafiltration versus advanced organ support (ADVOS) for critically ill patients with hyperbilirubinemia and acute-on-chronic liver failure (ACLF). BMC Nephrol. 2025 Aug 4;26(1):432. doi: 10.1186/s12882-025-04342-6.
- Background: PubMed 40796412Toapanta-Gaibor D, Sanchez-Ballesteros J, Gonzalez-Fernandez M, Broch-Porcar MJ. Advances in extracorporeal liver support for acute and acute-on-chronic liver failure. Med Intensiva (Engl Ed). 2025 Nov;49(11):502291. doi: 10.1016/j.medine.2025.502291. Epub 2025 Aug 11.
- Background: PubMed 29316579Karkmann K, Piecha F, Runzi AC, Schulz L, von Wulffen M, Benten D, Kluwe J, Wege H. [Management of compensated liver cirrhosis 2018 - Evidence based prophylactic measures]. Z Gastroenterol. 2018 Jan;56(1):55-69. doi: 10.1055/s-0043-124000. Epub 2018 Jan 9. German.
- Background: PubMed 33986443Scharf C, Liebchen U, Paal M, Becker-Pennrich A, Irlbeck M, Zoller M, Schroeder I. Successful elimination of bilirubin in critically ill patients with acute liver dysfunction using a cytokine adsorber and albumin dialysis: a pilot study. Sci Rep. 2021 May 13;11(1):10190. doi: 10.1038/s41598-021-89712-4.
- BackgroundDouble Plasma Molecular Adsorption System as Treatment in A Severe Acute-On-Chronic Liver Failure in A Patient with Autoimmune Hepatitis Author: Mariana Zavala-Gómez, Rodrigo López-Contreras, Daniel Alvarez-Lara, Carlos Cortez-Hernadez, Llia Rizo-Topete https://dx.doi.org/10.47746/FMCR.2025.6104
- Background: PubMed 36897008Xu W, Zhu S, Yang L, Li Z, Wu L, Zhang Y, Chen J, Deng Z, Luo Q, Peng L. Safety and efficacy of double plasma molecular adsorption system with sequential low-volume plasma exchange in intermediate-stage hepatitis B virus-related acute-on-chronic liver failure. J Med Virol. 2023 Mar;95(3):e28650. doi: 10.1002/jmv.28650.
- Background: PubMed 37263196Marcello M, Ronco C. Bilirubin Adsorption with DPMAS: Mechanism of Action and Efficacy of Anion Exchange Resin. Contrib Nephrol. 2023;200:201-209. doi: 10.1159/000526729. Epub 2023 Jun 1.
- Individual participant dataSharing planned: Yes. Data available upon reasonable request always with anonymity
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DPMAS plus plasma exchange in people with Acute on Chronic Liver Failure (ACLF), run by Unidade Local de Saude do Nordeste at 1 site in Portugal.
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 4 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Tiago B Loza, Graduated Physician (00351 913013068, tiago.loza@ulsne.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality or need for liver transplantation (time frame: From enrollment to 28 days after). 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 NCT07593638, which also lists 7 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 18 May 2026.