Combined DPMAS (double plasma molecular adsorption) and therapeutic plasma exchange to improve clotting, reduce inflammation, and support organs in acute liver failure

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.

We will test whether combining DPMAS (double plasma molecular adsorption) with therapeutic plasma exchange (TPE) helps adults in the ICU with acute liver failure or acute-on-chronic liver failure recover organ function or safely reach a transplant.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Institute for Clinical and Experimental Medicine (other gov)
• Locations: 1 site (Prague)
• Trial ID: NCT07329036 on ClinicalTrials.gov

What this trial studies

This interventional program delivers artificial liver support by combining a hemoadsorption system (DPMAS) with therapeutic plasma exchange (TPE) for adults with ALF or ACLF in the ICU. The protocol uses double plasma molecular adsorption followed by plasma exchange to remove toxins and inflammatory mediators while replacing plasma components. The primary focus is on effects on coagulation, inflammation, and the function of vital organs to permit liver parenchyma regeneration or to bridge patients to liver transplantation. Eligible participants are adults admitted to the center who are listed for transplant or indicated for support therapy but not for palliative care.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) hospitalized in the ICU with acute liver failure or acute-on-chronic liver failure who are listed for transplant or are appropriate for support therapy but not receiving palliative care.

Not a fit: Patients with an expected survival under 24 hours, ACLF-3, severe advanced lung, heart or neurological disease, advanced cancer, or severe frailty/sarcopenia are excluded and unlikely to benefit.

Why it matters

Potential benefit: If successful, the combined DPMAS+TPE approach could improve blood clotting, reduce inflammation, stabilize organ function, and either allow liver recovery or serve as a bridge to transplantation.

How similar studies have performed: Previous work with plasma exchange and hemoadsorption has shown short-term improvements in laboratory markers and temporary clinical stabilization, and combined DPMAS+TPE has some supportive but not definitive evidence for long-term survival benefit.

Eligibility criteria

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

Where this trial is running

Prague

• Institute for Clinical and Experimental Medicine (IKEM) — Prague, Czechia (RECRUITING)

Study contacts

• Study coordinator: Petr Piza, MD, MHA

Conditions: Acute Liver Failure, acute liver failure