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

Institute for Clinical and Experimental Medicine

Status: Enrolling

Conditions: Acute Liver Failure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07329036

Study1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

ALSS (alternating DPMAS and TPE)

Experimental group

Description:

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).

Treatment:

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

Standard care

No Intervention group

Description:

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