Precise Profiling of Liver Disease Patients With DPMAS Therapy, Treating Optimal Patients and Achieving Hard Endpoint (PADSTONE Study)

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: DPMAS Therapy in Liver Disease Patients

Treatments: Other: Double plasma molecular absorption system

Study type: Observational

Funder types: Other

Identifiers

NCT05129904

NFEC-2021-259

Details and patient eligibility

About

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.

Enrollment: 1,300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Hospitalized patients
2. Age >18 years
3. Chronic liver disease regardless of the etiology
4. Total bilirubin ≥ 12mg/dl and INR ≥ 1.5

Exclusion criteria

1. with more than three organ failures (SOFA criteria);
2. the pregnant;
3. 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;

5. 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.

Trial design

1,300 participants in 2 patient groups

Double plasma molecular absorption system treatment

Description:

Patients treat with DPMAS alone or in combination with plasma exchange

Treatment:

Other: Double plasma molecular absorption system

Standard medical therapy

Description:

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