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NCT Number: NCT07329036

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, inflammation and the function of vital organs.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 14200, Czechia

Location status: Recruiting

Location contact

Petr Piza, MD

CONTACT

[email protected]

+420602225077

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The artificial liver support system (ALSS) - DPMAS/TPE

Device

Device: Double Plasma Molecular Adsorption System (DPMAS) Procedure/Other: Therapeutic Plasma Exchange (TPE)

Primary outcomes

  1. Transplant-Free Survival at Day 21

    Time frame: 21 days after the first ALSS (DPMAS/TPE) session

    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).

Secondary outcomes

  1. Overall Survival at Day 21

    Time frame: 21 days after the first ALSS session

    Proportion of patients who are alive (with or without liver transplantation) at Day 21 after initiation of ALSS therapy.

  2. Overall Survival at Day 90

    Time frame: 90 days after the first ALSS session

    Proportion of patients who are alive (with or without liver transplantation) at Day 90 after initiation of ALSS therapy.

  3. Liver Transplantation Rate and Timing

    Time frame: Up to 90 days after the first ALSS session

    Proportion of patients who undergo liver transplantation after initiation of ALSS therapy and time from ALSS initiation to liver transplantation (days).

Other outcomes

  1. Change in Hepatic Encephalopathy Grade

    Time frame: Baseline (before first ALSS session) Daily for 7 days after ALSS initiation Day 14 Day 21

    West Haven grade (0-4)

  2. Change in Plasma Ammonia Concentration

    Time frame: 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

    µmol/L

  3. Change in International Normalized Ratio (INR)

    Time frame: 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

    Unit of Measure: INR units

  4. Change in C-reactive Protein (CRP) Concentration

    Time frame: Baseline 24 hours after each ALSS session 72 hours after the final ALSS session Day 7 Day 14

    mg/L

  5. Change in Global Liver Disease Severity (Model for End-Stage Liver Disease [MELD] Score)

    Time frame: Baseline; Day 3; Day 7; Day 14; Day 21

    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.

  6. Change From Baseline in Vasopressor Dose (Norepinephrine Equivalent Dose, NED)

    Time frame: Baseline; 24 hours after each ALSS session; daily until Day 7 (unit: µg/kg/min (norepinephrine equivalent))

    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).

  7. Incidence of Treatment-Emergent Adverse Events Related to ALSS (Combined DPMAS + TPE)

    Time frame: During each ALSS session; up to 7 days after the final ALSS session

    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.

  8. Change in Fibrinogen Concentration

    Time frame: 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

    Unit of Measure: g/L

  9. Change in Platelet Count

    Time frame: 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

    Unit of Measure: ×10⁹/L

  10. Change in Viscoelastic Clotting Time (ROTEM/TEG

    Time frame: 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

    Unit of Measure: Seconds

  11. Change in Maximum Clot Firmness (ROTEM/TEG)

    Time frame: 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

    Unit of Measure: mm

  12. Change in D-dimer Concentration

    Time frame: 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

    Unit of Measure: mg/L FEU

  13. Change in Coagulation Factor VIII Activity

    Time frame: 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

    Unit of Measure: % activity

  14. Change in von Willebrand Factor Antigen (vWF:Ag)

    Time frame: 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

    Unit of Measure: %

  15. Change in von Willebrand Factor Activity (vWF:RCo or vWF:GPIbM)

    Time frame: 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

    Unit of Measure: %

  16. Change in ADAMTS-13 Activity

    Time frame: 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

    Unit of Measure: % activity

  17. Change in Protein C Activity

    Time frame: 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

    Unit of Measure: % activity

  18. Change in Protein S Activity

    Time frame: 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

    Unit of Measure: % activity

  19. Change in Procalcitonin (PCT) Concentration

    Time frame: Baseline 24 hours after each ALSS session 72 hours after the final ALSS session Day 7 Day 14

    ng/mL

  20. Change in Interleukin-6 (IL-6) Concentration

    Time frame: Baseline 24 hours after each ALSS session 72 hours after the final ALSS session Day 7 Day 14

    pg/mL

  21. Change in Total Serum Bilirubin

    Time frame: Baseline Daily for 7 days Day 14 Day 21

    µmol/L

  22. Change in Alanine Aminotransferase (ALT)

    Time frame: Baseline Daily for 7 days Day 14 Day 21

    U/L

  23. Change in Aspartate Aminotransferase (AST)

    Time frame: Baseline Daily for 7 days Day 14 Day 21

    U/L

  24. Change in MELD Score (Model for End-Stage Liver Disease)

    Time frame: Baseline Day 3 Day 7 Day 14 Day 21

    Score on a scale from 6 to 40 Higher scores indicate worse liver disease severity.

  25. Change from baseline in serum creatinine.

    Time frame: Baseline Daily for 7 days Day 14 Day 21

    µmol/L

  26. Change in Blood Urea Nitrogen (BUN)

    Time frame: Baseline Daily for 7 days Day 14 Day 21

    mmol/L

  27. Change in Urine Output

    Time frame: Baseline Daily for 7 days Day 14 Day 21

    mL/kg/hour

  28. New requirement for renal replacement therapy compared with baseline.

    Time frame: Baseline Daily for 7 days Day 14 Day 21

    Yes/No

  29. Change from baseline in vasopressor dose expressed as norepinephrine-equivalent rate.

    Time frame: Baseline (before first ALSS session) 24 hours after each ALSS session Daily through Day 7

    µg/kg/min

  30. Change from baseline in mean arterial pressure

    Time frame: Baseline (before first ALSS session) 24 hours after each ALSS session Daily through Day 7

    mmHg

  31. Change from baseline in the ratio of arterial oxygen partial pressure to inspired oxygen fraction.

    Time frame: Baseline Day 3 Day 7 Day 14

    Ratio (unitless)

  32. New requirement for invasive mechanical ventilation compared with baseline

    Time frame: Baseline Day 3 Day 7 Day 14

    Yes/No

  33. ICU Length of Stay

    Time frame: From ICU admission to ICU discharge, up to 28 days after ICU admission

    ICU length of stay is defined as the number of days from ICU admission (date/time) to ICU discharge (date/time).

  34. Duration of Total Hospital Admission (Hospital Length of Stay)

    Time frame: From hospital admission to hospital discharge, up to 90 days after hospital admission

    Hospital length of stay is defined as the number of days from hospital admission (date/time) to hospital discharge (date/time).

  35. Change From Baseline in Mean Arterial Pressure (MAP)

    Time frame: Baseline; 24 hours after each ALSS session; daily until Day 7 (unit: mmHg)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Kieslichova, ass. prof., MD, PhD

CONTACT

[email protected]

+420 261 363 350

Petr Piza, MD, MHA

CONTACT

[email protected]

+420 602 225 077

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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