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

Summary

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.

Conditions

• DPMAS Therapy in Liver Disease Patients

Interventions

OTHER

Double plasma molecular absorption system

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Tianjin Third Central Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Beijing YouAn Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Meng Chao Hepatobiliary Hospital of Fujian Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• The Ninth Hospital of Nanchang

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• The First Affiliated Hospital of Shanxi Medical University

  collaborator OTHER

• Taihe Hospital

  collaborator OTHER

• Shanghai Public Health Clinical Center of Fudan University

  collaborator UNKNOWN

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Beijing Ditan Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Sichuan Provincial People's Hospital

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• People's Hospital of Anshun City of Guizhou Province

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Chengdu Public Health Clinical Center

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  collaborator OTHER

• Shandong First Medical University

  collaborator OTHER

• The Second Hospital of Shandong University

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Hunan Provincial People's Hospital

  collaborator OTHER

• Zhengzhou University Affiliated Luoyang Centre Hospital

  collaborator UNKNOWN

• Hebei Medical University Third Hospital

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• Hainan People's Hospital

  collaborator OTHER

• Zunyi Medical College

  collaborator OTHER

• The Affiliated Hospital Of Guizhou Medical University

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• First People's Hospital of Foshan

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Capital Medical University

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Shanghai Public Health Clinical Centre

  collaborator UNKNOWN

• The First Hospital of Jilin University

  collaborator OTHER

• The First Hospital of Yunnan Province

  collaborator UNKNOWN

• Shandong Provincial Clinical Center for Public Health

  collaborator UNKNOWN

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Jinjun Chen, Doctor · Nanfang Hospital, Sourthern Medical University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-15

Primary Completion

2024-12-30

Completion

2026-09-30

Countries

• China

Study Locations