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

Recruiting

• Conditions: DPMAS Therapy in Liver Disease Patients
• Interventions: Other: Double plasma molecular absorption system

• Registration Number: NCT05129904
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-15
• Study First Submitted: 2021-10-31
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-22
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-18
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Double plasma molecular absorption system treatment	Double plasma molecular absorption system	Patients treat with DPMAS alone or in combination with plasma exchange

Primary Outcome Measures

Name	Time	Method
The rate of progression with 4 weeks	4 weeks	The progression of ACLF with 4 weeks
The 4-week transplant-free mortality	4 weeks	The 4-week transplant-free mortality

Secondary Outcome Measures

Name	Time	Method
The transplant-free mortality within 12 weeks	12 weeks	The transplant-free mortality within 12 weeks
The improvement of ACLF with 12 weeks	12 weeks	The improvement of ACLF with 12 weeks

Trial Locations

Locations (1)

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China