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 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.

Conditions

• DPMAS Therapy in Liver Disease Patients

Interventions

OTHER

Double plasma molecular absorption system

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. DPMAS 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

Sponsors & Collaborators

• Xiangya Hospital of Central South University

  collaborator OTHER

• 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

• Beijing 302 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

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

  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

• Shanghai Public Health Clinical Center

  collaborator OTHER_GOV

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• The First Hospital of Jilin University

  collaborator OTHER

• 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

• The First Hospital of Yunnan Province

  collaborator UNKNOWN

• Chengdu Public Health Clinical Center

  collaborator UNKNOWN

• Ruijin Hospital

  collaborator OTHER

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  collaborator OTHER

• Shandong Provincial Clinical Center for Public Health

  collaborator UNKNOWN

• 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

• Union Hospital, Tongji Medical College

  collaborator UNKNOWN

• 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

• The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine

  collaborator UNKNOWN

• 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

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

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

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-15

Primary Completion

2023-12-30

Completion

2024-12-30

Countries

• China

Study Locations