Plasma Exchange Half-dose and Extracorporeal Detoxification for ACLF

NCT07593638 | Not Yet Recruiting DMC

• 1 other identifier: Phoenix
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Acute on Chronic Liver Failure (ACLF)

Keywords

DPMAS; Plasma exchange; ACLF

Outcome Measures

Primary Outcomes (1)

• Mortality or need for liver transplantation

  28-day mortality and/or need for liver transplantation

  From enrollment to 28 days after

Secondary Outcomes (18)

• Total bilirrubin level

  Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks

• INR

  Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks

• SOFA

  Daily from date of randomization until ICU discharge or liver trasnplant up to 12 weeks.

• CLIF-C ACLF score

  Measur at day of randomization, 72h after and 7 days after

• Mortality or liver transplant at day 90

  90 days after randomization

Study Arms (2)

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

Device: DPMAS plus plasma exchange

Interventions

DPMAS plus plasma exchange DEVICE

Use of extracorporal technique to support patients with acute on chronic liver failure

DPMAS plus Plasma exchange

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unidade Local de Saude do Nordeste: lead

Study Sites (1)

Unidade Hospitalar de Bragança

Bragança, Braganza District, 5301-852, Portugal

Location

Related Publications (7)

• 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.

  PMID: 40759919 BACKGROUND

• Toapanta-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.

  PMID: 40796412 BACKGROUND

• Karkmann 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.

  PMID: 29316579 BACKGROUND

• Scharf 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.

  PMID: 33986443 BACKGROUND

• Double 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

• 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.

  PMID: 36897008 BACKGROUND

• Marcello 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.

  PMID: 37263196 BACKGROUND

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Central Study Contacts

Tiago B Loza, Graduated Physician

CONTACT

00351 913013068; tiago.loza@ulsne.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Main investigator

Model Details: 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,

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: End date
• Access Criteria: For investigational use

Locations

PT (1)