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

ConditionAcute Liver Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitute for Clinical and Experimental Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Device

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

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: ALSS (alternating DPMAS and TPE)Experimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Transplant-Free Survival at Day 21

Proportion of patients with acute liver failure who are alive without liver transplantation at Day 21 after initiation of artificial liver support therapy (combined DPMAS + TPE).

Time frame
21 days after the first ALSS (DPMAS/TPE) session

Secondary outcomes

1

Overall Survival at Day 21

Proportion of patients who are alive (with or without liver transplantation) at Day 21 after initiation of ALSS therapy.

Time frame
21 days after the first ALSS session
2

Overall Survival at Day 90

Proportion of patients who are alive (with or without liver transplantation) at Day 90 after initiation of ALSS therapy.

Time frame
90 days after the first ALSS session
3

Liver Transplantation Rate and Timing

Proportion of patients who undergo liver transplantation after initiation of ALSS therapy and time from ALSS initiation to liver transplantation (days).

Time frame
Up to 90 days after the first ALSS session

Other outcomes

1

Change in Hepatic Encephalopathy Grade

West Haven grade (0-4)

Time frame
Baseline (before first ALSS session) Daily for 7 days after ALSS initiation Day 14 Day 21
2

Change in Plasma Ammonia Concentration

µmol/L

Time frame
Baseline (within 6 hours before first ALSS session) Immediately after each ALSS session 24 hours after the final ALSS session Day 3, Day 7, Day 14, Day 21
3

Change in International Normalized Ratio (INR)

Unit of Measure: INR units

Time frame
Baseline: Within 1 hour before the first DPMAS + TPE session Immediate Post-Procedure: Within 1 hour after each ALSS session Early Post-Intervention: 24 hours after the final ALSS session Follow-Up: Day 3 and Day 7
4

Change in C-reactive Protein (CRP) Concentration

mg/L

Time frame
Baseline 24 hours after each ALSS session 72 hours after the final ALSS session Day 7 Day 14

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute for Clinical and Experimental Medicine

Lead sponsor

Source ClinicalTrials.gov
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