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.
Status: Recruiting
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Contact Information
Primary
Petr Piza, MD, MHA
petr.piza@ikem.cz
+420 602 225 077
Backup
Eva Kieslichova, ass. prof., MD, PhD
evki@ikem.cz
+420 261 363 350
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 25
Treatments
Experimental: 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).
No_intervention: 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).
Related Therapeutic Areas
Sponsors
Leads: Institute for Clinical and Experimental Medicine