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NCT Number: NCT05129904

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

Acute-on-chronic liver failure (ACLF) is a life-threatening syndrome occurring in patients with chronic liver disease. In China, hepatitis B virus (HBV) is the main cause of cirrhosis. HBV related ACLF is characterized by multiple organs failure (liver, coagulation and kidney, etc.) and confers with high risk of short-term mortality. For the treatment of ACLF patients, recent studies have explored the therapeutic efficacy of extracorporeal liver support therapies, such as albumin dialysis, plasma exchange. However, the clinical efficacy remains to be fully elucidated. Liver transplantation is the most efficient way to improve the survival of ACLF patients, especially for those suffering from three or more organ failures.

Recently, a novel extracorporeal system which is called double plasma molecular adsorption system (DPMAS) has been applied for the treatment of ACLF patients. DPMAS is an extracorporeal therapeutic procedure that combines two hemoperfusion devices. During treatment, toxic plasma is isolated and purified via perfusion through two adsorbers, after which the purified plasma is reinfused back into the patient's circulation. This technique requires no massive plasma supply and avoids the risks of plasma-related allergic reactions and pathogen transmission. DPMAS can rapidly alleviate jaundice and lower serum bilirubin levels, thereby mitigating the hepatotoxic effects induced by excessive bilirubin and bile acids. Despite the widespread clinical application of DPMAS in patients with liver failure, high-quality evidence supporting its definite clinical efficacy remains insufficient.

Accordingly, this prospective, multicenter cluster-controlled study is designed to evaluate the clinical benefits of DPMAS via validated hard clinical endpoints, including short-term mortality and disease progression, and screen out suitable candidate patients. Furthermore, biological specimens including plasma, urine and feces will be collected to characterize the molecular profiles of ACLF patients receiving DPMAS treatment through multi-omics analyses.

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Key information

Conditions

DPMAS Therapy in Liver Disease Patients Acute-On-Chronic Liver Failure Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • With ≥ 3 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);
  • Human immunodeficiency virus (HIV) infection without treatment;
  • Patients with unstable hemodynamics caused by infection or acute bleeding;
  • Hospital stays <48 hours;
  • Diagnosis of hepatocellular carcinoma during screening period;
  • For the DPMAS clusters: patients decline to receive DPMAS treatment alone or in combination with PE;
  • For the SOC clusters: patients plan to receive DPMAS therapy;
  • Not suitable to participate in this study judging by researchers (e.g., patients with severe advanced pancreatic tumors, hematological tumors);
  • Not sign the informed consent.

Treatment and study plan

Double plasma molecular absorption system

Other

As a type of ECLS, double plasma molecular adsorption system (DPMAS) integrates plasma filtration with two specific adsorption membranes, which can efficiently remove bilirubin and the middle-molecular toxins, respectively. In the DPMAS clusters, patients receive at least one DPMAS treatment session during the study period, as treatment details regarding the number of DPMAS sessions and session intervals are made upon institutional protocols. DPMAS treatment can be applied either alone or in combination with PE, and both modalities are permitted in this study. PE is allowed in both groups as standard supportive care.

Other names: DPMAS treatment

Primary outcomes

  1. The rate of progression within 4 weeks

    Time frame: 4 weeks

    The progression of ACLF within 4 weeks

  2. The 4-week transplant-free mortality

    Time frame: 4 weeks

    The 4-week transplant-free mortality

Secondary outcomes

  1. The transplant-free mortality within 12 weeks

    Time frame: 12 weeks

    The transplant-free mortality within 12 weeks

  2. The progression of ACLF within 12 weeks

    Time frame: 12 weeks

    The progression rate of ACLF within 12 weeks

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Beijing Ditan Hospital
  • Beijing YouAn Hospital
  • Capital Medical University
  • Chengdu Public Health Clinical Center
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Affiliated Hospital of Fujian Medical University
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Xinjiang Medical University
  • First Affiliated Hospital of Zhejiang University
  • First People's Hospital of Foshan
  • General Hospital of Ningxia Medical University
  • Hainan People's Hospital
  • Hebei Medical University Third Hospital
  • Henan Provincial People's Hospital
  • Huashan Hospital
  • Hunan Provincial People's Hospital
  • LanZhou University
  • Meng Chao Hepatobiliary Hospital of Fujian Medical University
  • Peking University People's Hospital
  • People's Hospital of Anshun City of Guizhou Province
  • People's Hospital of Guangxi Zhuang Autonomous Region
  • Qilu Hospital of Shandong University
  • Ruijin Hospital
  • Second Affiliated Hospital of Guangzhou Medical University
  • Second Affiliated Hospital of Nanchang University
  • Second Xiangya Hospital of Central South University
  • Shandong First Medical University
  • Shandong Provincial Clinical Center for Public Health
  • Shandong Provincial Hospital
  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital
  • Shanghai Public Health Clinical Center of Fudan University
  • Shanghai Public Health Clinical Centre
  • Sichuan Provincial People's Hospital
  • Southwest Hospital, China
  • Taihe Hospital
  • The Affiliated Hospital Of Guizhou Medical University
  • The Affiliated Hospital of Xuzhou Medical University
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • The First Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital of Shanxi Medical University
  • The First Affiliated Hospital of Zhengzhou University
  • The First Hospital of Jilin University
  • The First Hospital of Yunnan Province
  • The Ninth Hospital of Nanchang
  • The Second Affiliated Hospital of Chongqing Medical University
  • The Second Affiliated Hospital of Kunming Medical University
  • The Second Hospital of Hebei Medical University
  • The Second Hospital of Shandong University
  • Tianjin Third Central Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • West China Hospital
  • Xiangya Hospital of Central South University
  • Zhengzhou University Affiliated Luoyang Centre Hospital
  • Zunyi Medical College

Registry information

Official study title

Precise Profiling of Liver Disease Patients With DPMAS Therapy, Treating Optimal Patients and Achieving Hard Endpoint: a Multicenter, Cluster-controlled Study (PADSTONE Study)

Acronym: PADSTONE

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Nov 22, 2021
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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