ALSS - DPMAS and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation, Inflammation and the Function of Vital Organs in ALF or ACLF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The artificial liver support system (ALSS) - DPMAS/TPE.
- Who it may be relevant to
- Registry conditions: Acute Liver Failure. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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
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.
Interventions
- Device The artificial liver support system (ALSS) - DPMAS/TPE
Device: Double Plasma Molecular Adsorption System (DPMAS) Procedure/Other: Therapeutic Plasma Exchange (TPE)
Primary outcome measures
- Transplant-Free Survival at Day 21 [Time frame: 21 days after the first ALSS (DPMAS/TPE) session]
Secondary outcome measures (3)
- Overall Survival at Day 21 [Time frame: 21 days after the first ALSS session]
- Overall Survival at Day 90 [Time frame: 90 days after the first ALSS session]
- Liver Transplantation Rate and Timing [Time frame: Up to 90 days after the first ALSS session]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Czechia · 1 center
- Institute for Clinical and Experimental Medicine (IKEM) — Prague
Identifiers
NCT: NCT07329036 · Study1