ALSS - DPMAS and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation, Inflammation and the Function of Vital Organs in ALF or ACLF

The Artificial Liver Support System (ALSS) in Patients With Acute on Chronic Liver Failure - the Use of Combined Molecular Adsorption System With Double Plasma (DPMAS) and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation and the Function of Vital Organs.

The artificial liver support system (ALSS) in patients with acute on chronic liver failure - the use of combined molecular adsorption system with double plasma (DPMAS) and therapeutic plasma exchange (TPE), its effect on primary coagulation, inflammation and the function of vital organs.

Study Overview

• Status: Recruiting
• Conditions: Acute Liver Failure
• Intervention / Treatment: Device: The artificial liver support system (ALSS) - DPMAS/TPE

Detailed Description

In patients with ACLF we assume the use of the proposed protocol of combined support therapy (consisting of a hemoadsorption system - DPMAS (double plasma molecular absorption system) and therapeutic plasma (TPE), with the basic aim of improving clinical condition (organ dysfunction) to allow the regeneration of liver parenchyma or to perform liver transplantation.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petr Piza, MD, MHA; Phone Number: +420 602 225 077; Email: petr.piza@ikem.cz
• Study Contact Backup: Name: Eva Kieslichova, ass. prof., MD, PhD; Phone Number: +420 261 363 350; Email: evki@ikem.cz

Study Locations

• Czechia
  • Prague, Czechia, 14200
    • Recruiting
    • Institute for Clinical and Experimental Medicine (IKEM)
    • Contact: Petr Piza, MD; Phone Number: +420602225077; Email: petr.piza@ikem.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patient, age ≥18 years
• Expressed consent to the inclusion
• Patient hospitalized on ICU with ALF or ACLF diagnosis
• Recently meeting the inclusion to liver transplantation
• Present on a waiting list to liver transplant
• Unsuitable for inclusion to liver transplantation - indicated for support therapy only, but not indented to palliative care

Exclusion Criteria:

• Disagreement with the study
• Infaust prognosis with expected survival less than 24 hours
• Physiologically/biologically very advanced stage patients condition, severe lung disease (Gold criteria 3 or 4), heart failure (functional class NYHA III or IV) or neurological disease, as well as ACLF-3.
• Advanced oncological disease (expected life expectancy below 6 months)
• Severe degree of Frailty syndrome in secondary severe sarcopenia (muscle and malnutrition) or reduced performance state according

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALSS (alternating DPMAS and TPE); Participants meeting inclusion criteria will receive artificial liver support system (ALSS) therapy in addition to standard of care. ALSS sessions will be performed for up to 7-10 days or until liver transplantation or recovery of hepatic function, whichever occurs first. ALSS modalities will be alternated according to protocol (DPMAS and TPE alternating between sessions). Outcomes will be assessed through Day 28 after hospital admission (or per protocol).	Device: The artificial liver support system (ALSS) - DPMAS/TPE; Device: Double Plasma Molecular Adsorption System (DPMAS) Procedure/Other: Therapeutic Plasma Exchange (TPE)
No Intervention: Standard care; Participants will receive standard of care for ACLF according to institutional protocol without ALSS (no DPMAS and no TPE as part of ALSS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transplant-Free Survival at Day 21	Proportion of patients with acute liver failure who are alive without liver transplantation at Day 21 after initiation of artificial liver support therapy (combined DPMAS + TPE).	21 days after the first ALSS (DPMAS/TPE) session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival at Day 21	Proportion of patients who are alive (with or without liver transplantation) at Day 21 after initiation of ALSS therapy.	21 days after the first ALSS session
Overall Survival at Day 90	Proportion of patients who are alive (with or without liver transplantation) at Day 90 after initiation of ALSS therapy.	90 days after the first ALSS session
Liver Transplantation Rate and Timing	Proportion of patients who undergo liver transplantation after initiation of ALSS therapy and time from ALSS initiation to liver transplantation (days).	Up to 90 days after the first ALSS session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hepatic Encephalopathy Grade	West Haven grade (0-4)	Baseline (before first ALSS session) Daily for 7 days after ALSS initiation Day 14 Day 21
Change in Plasma Ammonia Concentration	µmol/L	Baseline (within 6 hours before first ALSS session) Immediately after each ALSS session 24 hours after the final ALSS session Day 3, Day 7, Day 14, Day 21
Change in International Normalized Ratio (INR)	Unit of Measure: INR units	Baseline: Within 1 hour before the first DPMAS + TPE session Immediate Post-Procedure: Within 1 hour after each ALSS session Early Post-Intervention: 24 hours after the final ALSS session Follow-Up: Day 3 and Day 7
Change in C-reactive Protein (CRP) Concentration	mg/L	Baseline 24 hours after each ALSS session 72 hours after the final ALSS session Day 7 Day 14
Change in Global Liver Disease Severity (Model for End-Stage Liver Disease [MELD] Score)	Change from baseline in the Model for End-Stage Liver Disease (MELD) score, a validated severity scale of chronic liver disease. The MELD score is calculated from serum bilirubin, serum creatinine, and INR (International Normalized Ratio). Score range: 6 to 40, with higher scores indicating more severe liver disease and worse prognosis. Change from baseline will be calculated at each time point as: (MELD at time point - MELD at baseline). MELD will be calculated using the standard formula.	Baseline; Day 3; Day 7; Day 14; Day 21
Change From Baseline in Vasopressor Dose (Norepinephrine Equivalent Dose, NED)	Norepinephrine equivalent dose (NED) will be recorded at baseline, 24 hours after each ALSS session, and then daily through Day 7. Change from baseline will be calculated at each time point as: (NED at time point - NED at baseline).	Baseline; 24 hours after each ALSS session; daily until Day 7 (unit: µg/kg/min (norepinephrine equivalent))
Incidence of Treatment-Emergent Adverse Events Related to ALSS (Combined DPMAS + TPE)	Number of participants with treatment-emergent adverse events (TEAEs) considered related to ALSS (combined DPMAS + TPE) occurring during each ALSS session or within 7 days after the final ALSS session, including: procedure-related bleeding, hemodynamic instability during the procedure, allergic or anaphylactic reactions, circuit clotting, and clinically significant electrolyte disturbances requiring intervention. Relationship to ALSS will be assessed by the investigator according to predefined criteria.	During each ALSS session; up to 7 days after the final ALSS session
Change in Fibrinogen Concentration	Unit of Measure: g/L	Baseline: Within 1 hour before first DPMAS + TPE session Immediate Post-Procedure: Within 1 hour after each ALSS session Early Post-Intervention: 24 hours after the final ALSS session Follow-Up: Day 3 and Day 7
Change in Platelet Count	Unit of Measure: ×10⁹/L	Baseline: Within 1 hour before first DPMAS + TPE session Post-Procedure: Within 12 hour after each ALSS session Early Post-Intervention: 24 hours after the final ALSS session Follow-Up: Day 3 and Day 7
Change in Viscoelastic Clotting Time (ROTEM/TEG	Unit of Measure: Seconds	Baseline: Within 1 hour before first DPMAS + TPE session Post-Procedure: Within 2 hour after each ALSS session Early Post-Intervention: 24 hours after the final ALSS session Follow-Up: Day 3 and Day 7
Change in Maximum Clot Firmness (ROTEM/TEG)	Unit of Measure: mm	Baseline: Within 1 hour before first DPMAS + TPE session Post-Procedure: Within 2 hour after each ALSS session Early Post-Intervention: 24 hours after the final ALSS session Follow-Up: Day 3 and Day 7
Change in D-dimer Concentration	Unit of Measure: mg/L FEU	Baseline: Within 1 hour before first DPMAS + TPE session Immediate Post-Procedure: Within 12 hour after each ALSS session Early Post-Intervention: 24 hours after the final ALSS session Follow-Up: Day 3 and Day 7
Change in Coagulation Factor VIII Activity	Unit of Measure: % activity	Baseline: Within 1 hour before first DPMAS + TPE session Immediate Post-Procedure: Within 1 hour after each ALSS session Early Post-Intervention: 24 hours after the final ALSS session Follow-Up: Day 3 and Day 7
Change in von Willebrand Factor Antigen (vWF:Ag)	Unit of Measure: %	Baseline: Within 1 hour before first DPMAS + TPE session Immediate Post-Procedure: Within 1 hour after each ALSS session Early Post-Intervention: 24 hours after the final ALSS session Follow-Up: Day 3 and Day 7
Change in von Willebrand Factor Activity (vWF:RCo or vWF:GPIbM)	Unit of Measure: %	Baseline: Within 1 hour before first DPMAS + TPE session Immediate Post-Procedure: Within 1 hour after each ALSS session Early Post-Intervention: 24 hours after the final ALSS session Follow-Up: Day 3 and Day 7
Change in ADAMTS-13 Activity	Unit of Measure: % activity	Baseline: Within 1 hour before first DPMAS + TPE session Immediate Post-Procedure: Within 1 hour after each ALSS session Early Post-Intervention: 24 hours after the final ALSS session Follow-Up: Day 3 and Day 7
Change in Protein C Activity	Unit of Measure: % activity	Baseline: Within 1 hour before first DPMAS + TPE session Immediate Post-Procedure: Within 1 hour after each ALSS session Early Post-Intervention: 24 hours after the final ALSS session Follow-Up: Day 3 and Day 7
Change in Protein S Activity	Unit of Measure: % activity	Baseline: Within 1 hour before first DPMAS + TPE session Immediate Post-Procedure: Within 1 hour after each ALSS session Early Post-Intervention: 24 hours after the final ALSS session Follow-Up: Day 3 and Day 7
Change in Procalcitonin (PCT) Concentration	ng/mL	Baseline 24 hours after each ALSS session 72 hours after the final ALSS session Day 7 Day 14
Change in Interleukin-6 (IL-6) Concentration	pg/mL	Baseline 24 hours after each ALSS session 72 hours after the final ALSS session Day 7 Day 14
Change in Total Serum Bilirubin	µmol/L	Baseline Daily for 7 days Day 14 Day 21
Change in Alanine Aminotransferase (ALT)	U/L	Baseline Daily for 7 days Day 14 Day 21
Change in Aspartate Aminotransferase (AST)	U/L	Baseline Daily for 7 days Day 14 Day 21
Change in MELD Score (Model for End-Stage Liver Disease)	Score on a scale from 6 to 40 Higher scores indicate worse liver disease severity.	Baseline Day 3 Day 7 Day 14 Day 21
Change from baseline in serum creatinine.	µmol/L	Baseline Daily for 7 days Day 14 Day 21
Change in Blood Urea Nitrogen (BUN)	mmol/L	Baseline Daily for 7 days Day 14 Day 21
Change in Urine Output	mL/kg/hour	Baseline Daily for 7 days Day 14 Day 21
New requirement for renal replacement therapy compared with baseline.	Yes/No	Baseline Daily for 7 days Day 14 Day 21
Change from baseline in vasopressor dose expressed as norepinephrine-equivalent rate.	µg/kg/min	Baseline (before first ALSS session) 24 hours after each ALSS session Daily through Day 7
Change from baseline in mean arterial pressure	mmHg	Baseline (before first ALSS session) 24 hours after each ALSS session Daily through Day 7
Change from baseline in the ratio of arterial oxygen partial pressure to inspired oxygen fraction.	Ratio (unitless)	Baseline Day 3 Day 7 Day 14
New requirement for invasive mechanical ventilation compared with baseline	Yes/No	Baseline Day 3 Day 7 Day 14
ICU Length of Stay	ICU length of stay is defined as the number of days from ICU admission (date/time) to ICU discharge (date/time).	From ICU admission to ICU discharge, up to 28 days after ICU admission
Duration of Total Hospital Admission (Hospital Length of Stay)	Hospital length of stay is defined as the number of days from hospital admission (date/time) to hospital discharge (date/time).	From hospital admission to hospital discharge, up to 90 days after hospital admission
Change From Baseline in Mean Arterial Pressure (MAP)	Mean arterial pressure (MAP) will be recorded at baseline, 24 hours after each ALSS session, and then daily through Day 7. Change from baseline will be calculated at each time point as: (MAP at time point - MAP at baseline).	Baseline; 24 hours after each ALSS session; daily until Day 7 (unit: mmHg)

Collaborators and Investigators

• Sponsor: Institute for Clinical and Experimental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: December 28, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: acute liver failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; Liver Failure, Acute
• Other Study ID Numbers: Study1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No