Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07329036

The Artificial Liver Support System (ALSS) in Patients With Acute on Chronic Liver Failure - Combined Molecular Adsorption System With Double Plasma (DPMAS) and Therapeutic Plasma Exchange (TPE) and Its Effects on Coagulation and Vital Organ Function

Led by Institute for Clinical and Experimental Medicine · Updated on 2026-01-09

25

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the artificial liver support system (ALSS) for patients with acute on chronic liver failure (ACLF) or acute liver failure (ALF). The study aims to assess the effects of a combined molecular adsorption system with double plasma (DPMAS) and therapeutic plasma exchange (TPE) on primary blood clotting, inflammation, and the function of vital organs. This approach seeks to improve clinical conditions and support liver regeneration or prepare patients for liver transplantation. Participants are divided into two groups: one receives ALSS therapy alongside standard care, and the other receives standard care alone without ALSS. ALSS sessions involve alternating treatments with DPMAS and TPE, conducted for up to 7 to 10 days or until liver transplantation or recovery of liver function. The study does not involve randomization or masking. During the study, participants will be monitored for survival without liver transplant at 21 days after the first ALSS session, along with overall survival rates at 21 and 90 days. Researchers will also track the liver transplantation rate and timing within 90 days. The study involves hospitalized patients in intensive care units and includes assessments of organ function and coagulation. Participants may be followed up through day 28 and beyond for outcome evaluations.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient aged 18 years or older
  • Expressed consent to participate
  • Hospitalized in intensive care unit with diagnosis of acute liver failure or acute on chronic liver failure
  • Recently eligible for liver transplantation
  • Listed for liver transplantation
  • Not eligible for liver transplantation but indicated for support therapy and not palliative care
Not Eligible

You will not qualify if you...

  • Disagreement with study participation
  • Expected survival less than 24 hours
  • Severe advanced condition including severe lung disease (Gold criteria 3 or 4), heart failure (NYHA class III or IV), neurological disease, or ACLF-3
  • Advanced cancer with life expectancy under 6 months
  • Severe frailty syndrome with muscle loss and malnutrition or reduced performance status

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 7 to 10 days or until liver transplantation or recovery of hepatic function

Participants receive artificial liver support system (ALSS) therapy consisting of alternating sessions of Double Plasma Molecular Adsorption System (DPMAS) and Therapeutic Plasma Exchange (TPE) in addition to standard care. Treatment lasts up to 7 to 10 days or until liver transplantation or recovery of hepatic function, whichever occurs first.

Multiple ALSS sessions over the treatment period

Follow-up

Duration - Up to 28 days after hospital admission

Participants are monitored for clinical outcomes including survival and liver transplantation status after completion of treatment.

Visits for outcome assessments through Day 28

Trial Site Locations

Total: 1 location

1

Institute for Clinical and Experimental Medicine (IKEM)

Prague, Czechia, 14200

Actively Recruiting

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Research Team

P

Petr Piza, MD, MHA

E

Eva Kieslichova, ass. prof., MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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