Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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