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

NCT ID: NCT07329036

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Liver Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALSS (alternating DPMAS and TPE)

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).

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Petr Piza

anesthesiologist/intensivist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute for Clinical and Experimental Medicine (IKEM)

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Petr Piza, MD, MHA

Role: CONTACT

+420 602 225 077

Eva Kieslichova, ass. prof., MD, PhD

Role: CONTACT

+420 261 363 350

Facility Contacts

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Petr Piza, MD

Role: primary

+420602225077

Other Identifiers

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Study1

Identifier Type: -

Identifier Source: org_study_id

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