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

NCT07329036 | Recruiting

• 1 other identifier: Study1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Liver Failure

Keywords

acute liver failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Survival at Day 21

  21 days after the first ALSS session

• Overall Survival at Day 90

  90 days after the first ALSS session

• Liver Transplantation Rate and Timing

  Up to 90 days after the first ALSS session

Other Outcomes (35)

• Change in Hepatic Encephalopathy Grade

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

• Change in Plasma Ammonia Concentration

  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)

  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

Study Arms (2)

ALSS (alternating DPMAS and TPE)

EXPERIMENTAL

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

Standard care

NO INTERVENTION

Participants will receive standard of care for ACLF according to institutional protocol without ALSS (no DPMAS and no TPE as part of ALSS).

Interventions

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

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

ALSS (alternating DPMAS and TPE)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient, age ≥18 years
• Patient hospitalized on ICU with ALF or ACLF diagnosis
• Present on a waiting list to liver transplant

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 14200, Czechia

RECRUITING

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Petr Piza, MD, MHA

CONTACT

+420 602 225 077; petr.piza@ikem.cz

Eva Kieslichova, ass. prof., MD, PhD

CONTACT

+420 261 363 350; evki@ikem.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiologist/intensivist

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: January 9, 2026
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)