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
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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RECRUITING
NA
25 participants
INTERVENTIONAL
2024-04-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
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).
The artificial liver support system (ALSS) - DPMAS/TPE
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).
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Institute for Clinical and Experimental Medicine
OTHER_GOV
Responsible Party
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Petr Piza
anesthesiologist/intensivist
Locations
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Institute for Clinical and Experimental Medicine (IKEM)
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Study1
Identifier Type: -
Identifier Source: org_study_id
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