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

  • STATUS
    Recruiting
  • participants needed
    1300
  • sponsor
    Nanfang Hospital of Southern Medical University
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Updated on 23 November 2021
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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.

Details
Condition DPMAS Therapy in Liver Disease Patients
Age 18years - 80years
Treatment Double plasma molecular absorption system
Clinical Study IdentifierNCT05129904
SponsorNanfang Hospital of Southern Medical University
Last Modified on23 November 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Three or more organ failure (SOFA criteria)
Pregnant
With serve chronic non-liver organ failure
HIV infection without treatment
Unstable hemodynamics caused by acute bleeding
Proven infection with fever (>37.5°C) or hemodynamically-instable
The diagnosis of hepatocellular carcinoma during screening period
Hospital stays <48 hours
Patients unwilling to treat with DPMAS alone or in combination with plasma exchange (suitable for the DPMAS treatment group)
Patients with DPMAS treatment or other artificial liver support system (suitable for Standard medical therapy group)
Not sign the informed consent
Not suitable to participate in this study judging by the researchers
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