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Precise Profiling of Liver Disease Patients With DPMAS Therapy, Treating Optimal Patients and Achieving Hard Endpoint (PADSTONE Study)
Sponsor: Nanfang Hospital, Southern Medical University
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.
Official title: Precise Profiling of Liver Disease Patients With DPMAS Therapy, Treating Optimal Patients and Achieving Hard Endpoint: a Multicenter, Cluster-controlled Study (PADSTONE Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1300
Start Date
2021-09-15
Completion Date
2026-09-30
Last Updated
2026-05-26
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (56)
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Nanfang Hospital
Guangzhou, Guangdong, China
The Third Hospital of Hebei Medical University
Hebei, Hebei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Clinical Center for Public Health
Jinan, Shandong, China
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
The Second Hospital of Shandong University
Jinan, Shandong, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The First Hospital of Yunnan Province
Kunming, Yunnan, China
Beijing Ditan Hospital, Capital Medical University
Beijing, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
Luhe Hospital, Capital Medical University
Beijing, China
Peking University People's Hospital
Beijing, China
The Second Xiangya Hospital, Central South University
Changsha, China
Chengdu Public Health Clinical Center
Chengdu, China
Southwest Hospital, Third Military Medical University
Chongqing, China
The First People's Hospital of Foshan
Foshan, China
First Affiliated Hospital of Fujian Medical University
Fujian, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fujian, China
The First Affiliated Hospital of Guangxi Medical University
Guangxi, China
The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Guangxi, China
The Second Affiliated Hospital of Guangxi Medical University
Guangxi, China
Guizhou Provincial People's Hospital
Guizhou, China
The Affiliated Hospital of Guizhou Medical University
Guizhou, China
The Affiliated Hospital of Zunyi Medical University
Guizhou, China
Hainan Provincial People's Hospital
Hainan, China
The Second Hospital of Hebei Medical University
Hebei, China
First Affiliated Hospital of Anhui Medical University
Hefei, China
Henan Provincial People's Hospital
Henan, China
Taihe Hospital, Hubei University of Medicine
Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, China
The First Hospital of Lanzhou University
Lanzhou, China
Zhengzhou University Affiliated Luoyang Centre Hospital
Luoyang, China
Infectious Diseases Hospital Affiliated to Nanchang University
Nanchang, China
General Hospital of Ningxia Medical University
Qinghai, China
Huashan Hospital, Fudan University
Shanghai, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, China
Shanghai Public Health Clinical Centre, Fudan University
Shanghai, China
Shanghai Public Health Clinical Centre
Shanghai, China
The First Affiliated Hospital of Shanxi Medical University
Shanxi, China
Tianjin Third Central Hospital
Tianjin, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China