The Effects of Double Plasma Molecular Adsorption System in Acute on Chronic Liver Failure Patients
1 other identifier
interventional
40
1 country
1
Brief Summary
Acute liver failure patients posed high mortality rate despite receiving standard therapy. The severity and mortality even higher in patients with underlying liver disease. Acute liver failure cause hyperinflammatory response in early stage and immunoparalysis in later stage. The surge of proinflammatory cytokines leads to multiorgan failure and more liver injury. Subsequent immunoparalysis may lead to lethal secondary infections. Liver support system had been used in acute and acute ontop chronic liver disease for last several decades. Double plasma molecular adsorption system (DPMAS) is one of the promising non-biological liver support system that have been extensively investigated in acute ontop chronic liver failure from hepatits B viral. DPMAS circuit consist of BS330 (bilirubin adsorber) and HA330 (Cytokines adsorber). Thus, DPMAS can also remove various cytokines. The effect of DPMAS on immune function in these patients has not been explored. Recent randomized controlled trial by Srisawat et al. demonstrated improvement of mHLA-DR in septic shock patients who received polymyxin B extracorporeal therapy compare to control arm. Since liver failure show change of immunological profile resemble to sepsis. Investigators proposed that removal of toxic liver toxins and lethal cytokines by DPMAS will improve immunological profiles in acute ontop chronic liver failure patients. Investigators plan to conduct a randomized controlled trial in acute ontop chronic liver failure patients who admitted to intensive care unit. Investigators plan to compare the immunomodulatory effects of DPMAS with standard treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 26, 2021
CompletedFirst Posted
Study publicly available on registry
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedDecember 29, 2025
December 1, 2025
4 years
August 26, 2021
December 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mHLA-DR expression
mHLA-DR expression
7 days
Secondary Outcomes (5)
survival rate
28 days
Reduction of total bilirubin
7 days
hepatic encephalopathy grading
28 days
subsequent bacterial infection
28 days
CD11b expression
7 days
Study Arms (2)
Intervention
EXPERIMENTALIntervention group will receive DPMAS extracorporeal treatment one session per day for 3 consecutive days plus standard therapy. We plan to use blood flow rate of 100-120 ml/hour with filtration fraction for plasma separation of 25-30%. DPMAS circuit consist of Plasmaflo OP cartridge (Asahi Medical, Tokyo, Japan), Ion exchange resin hemoperfusion cartridge (BS330; Jafron, Zhuhai City, China), and Neutral adsorption resin hemoperfusion cartridge (HA330-II; Jafron, Zhuhai City, China) We do not use any anticoagulant.
Standard care
ACTIVE COMPARATORStandard treatment according to EASL Clinical Practical Guidelines on the management of acute (fulminant) liver failure 2017
Interventions
DPMAS circuit consist of Plasmaflo OP cartridge (Asahi Medical, Tokyo, Japan), Ion exchange resin hemoperfusion cartridge (BS330; Jafron, Zhuhai City, China), and Neutral adsorption resin hemoperfusion cartridge (HA330-II; Jafron, Zhuhai City, China)
standard treatment according to EASL Clinical Practical Guidelines on the management of acute (fulminant) liver failure 2017.
Eligibility Criteria
You may qualify if:
- Age 18 or more
- Diagnosis of Acute ontop chronic liver failure by Asian Pacific association for the study of the liver (APASL) criteria
- Admitted to intensive care unit
You may not qualify if:
- Pregnancy
- Received steroid treatment
- Expected dead within 24 hour
- WBC \< 500/mm3
- Allergy to DPMAS
- History of organ transplant
- Terminal illness with do not resuscitation order
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Faculty of Medicine
Study Record Dates
First Submitted
August 26, 2021
First Posted
September 1, 2021
Study Start
January 1, 2021
Primary Completion
January 1, 2025
Study Completion
April 1, 2026
Last Updated
December 29, 2025
Record last verified: 2025-12