NCT05129904

Brief Summary

Acute-on-chronic liver failure (ACLF) is life-threaten syndrome in patients with chronic liver disease. In China, hepatitis B virus (HBV) is the main etiology of cirrhosis and HBV-ACLF is characterized by multiple organs failure (liver, coagulation and kidney, etc.) and associated with high risk of short-tern death. For the treatment of ACLF patients, recent studies investigated the efficiency of extracorporeal liver support, such as albumin dialysis, plasma exchange. However, the efficiencies remain unclear. Liver transplantation is the most efficient way to improve the survival of ACLF patients, especially for those patients with three or more organ failure. More recently，an extracorporeal system which is called double plasma molecular absorption system (DPMAS) was applied for the treatment of ACLF patients. DPMAS is an extracorporeal procedure that combines two hemoperfusion machines. During the procedure, toxic plasma is separated and cleansed by perfusion over two absorbers, and the final cleansed plasma is then returned to patients. It does not require large volumes of plasma and nor does it bear the risk of plasma-associated allergic reaction or disease transmissions. PMAS can attenuate the jaundice in a short term and decrease the bilirubin concentration, which then reduces the toxicities of bile acid and high levels of bilirubin on the hepatocytes. Although DPMAS treatment is applied in the clinical practice for those patients with liver failure, it still lack of compelling evidence in terms of real efficiency. Thus, in this prospective, multicenter and cluster-controlled study, the investigators aim to identify the optimal liver disease patients by using hard endpoints (short-term mortality and disease progression). Moreover, this study will collect biological samples, including plasma, urine and stool, to explore the precise profiling of ACLF patients with DPMAS therapy by multi-omics detection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

October 31, 2021

Last Update Submit

September 14, 2023

Conditions

DPMAS Therapy in Liver Disease Patients

Keywords

double plasma molecular absorption systemliver diseaseacute-on-chronic liver failuremortality

Outcome Measures

Primary Outcomes (2)

  • The rate of progression with 4 weeks

    The progression of ACLF with 4 weeks

    4 weeks

  • The 4-week transplant-free mortality

    The 4-week transplant-free mortality

    4 weeks

Secondary Outcomes (2)

  • The transplant-free mortality within 12 weeks

    12 weeks

  • The improvement of ACLF with 12 weeks

    12 weeks

Study Arms (2)

Double plasma molecular absorption system treatment

Patients treat with DPMAS alone or in combination with plasma exchange

Other: Double plasma molecular absorption system

Standard medical therapy

Patients with standard medical therapy except for DPMAS treatment or other artificial liver support system

Interventions

Double plasma molecular absorption systemOTHER

DPMAS is an extracorporeal procedure that combines two hemoperfusion machines. During the procedure, toxic plasma is separated and cleansed by perfusion over two absorbers, and the final cleansed plasma is then returned to patients. It does not require large volumes of plasma and nor does it bear the risk of plasma-associated allergic reaction or disease transmissions. DPMAS can attenuate the jaundice in a short term and decrease the bilirubin concentration, which then reduces the toxicities of bile acid and high levels of bilirubin on the hepatocytes

Also known as: DPMAS treatment
Double plasma molecular absorption system treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort 1: Liver failure patients (Total bilirubin ≥ 12mg/dl and INR ≥ 1.5) treat with DPMAS alone or in combination with plasma exchange Cohort 2: Liver failure patients (Total bilirubin ≥ 12mg/dl and INR ≥ 1.5) with standard medical therapy except for DPMAS treatment or other artificial liver support system

You may qualify if:

  • Hospitalized patients
  • Age \>18 years
  • Chronic liver disease regardless of the etiology
  • Total bilirubin ≥ 12mg/dl and INR ≥ 1.5

You may not qualify if:

  • with more than three organ failures (SOFA criteria);
  • the pregnant;
  • with severe non-hepatic disease (such as chronic obstructive pulmonary disease level IV, chronic kidney disease with end-stage renal failure, myocardial infarction within 3 months before admission); 4) human immunodeficiency virus (HIV) infection without treatment;
  • \) patients with unstable hemodynamics caused by infection or acute bleeding; 6) hospital stays \<48 hours; 7) diagnosis of hepatocellular carcinoma during screening period; 8) for the DPMAS clusters: patients unwilling to receive DPMAS treatment alone or in combination with PE; 9) for the SMT clusters: patients plan to receive DPMAS therapy or other ALSS; 10) not suitable to participate in this study judging by researchers; 11) not sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine，stool

MeSH Terms

Conditions

Liver DiseasesAcute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Digestive System DiseasesLiver Failure, AcuteLiver FailureHepatic Insufficiency

Study Officials

  • Jinjun Chen, Doctor

    Nanfang Hospital, Sourthern Medical University

    STUDY DIRECTOR

Central Study Contacts

Jinjun Chen, Doctor

CONTACT

18588531001chjj@smu.edu.cn

Beiling Li

CONTACT

13570541527820584791@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2021

First Posted

November 22, 2021

Study Start

September 15, 2021

Primary Completion

December 30, 2023

Study Completion

December 30, 2024

Last Updated

September 18, 2023

Record last verified: 2023-09

Locations

CN(1)