Precise Profiling of Liver Disease Patients With DPMAS Therapy, Treating Optimal Patients and Achieving Hard Endpoint (PADSTONE Study)
PADSTONE
1 other identifier
observational
1,300
1 country
56
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Longer than P75 for all trials
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2021
CompletedFirst Submitted
Initial submission to the registry
October 31, 2021
CompletedFirst Posted
Study publicly available on registry
November 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
ExpectedMay 26, 2026
May 1, 2026
3.3 years
October 31, 2021
May 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The rate of progression within 4 weeks
The progression of ACLF within 4 weeks
4 weeks
The 4-week transplant-free mortality
The 4-week transplant-free mortality
4 weeks
Secondary Outcomes (2)
The transplant-free mortality within 12 weeks
12 weeks
The progression of ACLF within 12 weeks
12 weeks
Study Arms (2)
Double plasma molecular absorption system treatment
Patients in DPMAS clusters receive at least one DPMAS treatment session (with or without plasma exchange) in this study.
Standard of care
Patients in the SOC clusters receive routine treatments other than DPMAS, in accordance with established clinical guidelines for the management of ACLF
Interventions
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.
Eligibility Criteria
Given the global heterogeneity of current regional diagnostic criteria for ACLF, the study enrolled a subgroup of patients with chronic liver disease (CLD) related ACLF defined by total bilirubin ≥ 12 mg/dL and INR level ≥ 1.5, which simultaneously fulfilled the diagnostic criteria recommended by Chinese and Asia-Pacific, while a considerable proportion also fulfilled the ACLF diagnostic criteria defined by European guidelines. This study population is characterized by markedly elevated bilirubin levels, making it well aligned with real-world clinical practice given that DPMAS intervention selectively targets bilirubin adsorption. Additionally, previous data have suggested that this specific patient population associated with a high rate of disease progression rate (approximately 40%) and high mortality (over 20%), further suggesting that the enrolled population is suitable for screening the optimal ACLF subgroup with favorable responses to DPMAS.
You may qualify if:
- Hospitalized patients
- Age \>18 years
- Chronic liver disease regardless of the etiology
- Total bilirubin ≥ 12mg/dl and INR ≥ 1.5
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- The First Affiliated Hospital of Nanchang Universitycollaborator
- Tianjin Third Central Hospitalcollaborator
- Henan Provincial People's Hospitalcollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Beijing YouAn Hospitalcollaborator
- The First Affiliated Hospital of Anhui Medical Universitycollaborator
- West China Hospitalcollaborator
- The Second Affiliated Hospital of Kunming Medical Universitycollaborator
- Meng Chao Hepatobiliary Hospital of Fujian Medical Universitycollaborator
- The Second Affiliated Hospital of Chongqing Medical Universitycollaborator
- First Affiliated Hospital of Zhejiang Universitycollaborator
- The Ninth Hospital of Nanchangcollaborator
- First Affiliated Hospital of Xinjiang Medical Universitycollaborator
- The First Affiliated Hospital of Shanxi Medical Universitycollaborator
- Taihe Hospitalcollaborator
- Shanghai Public Health Clinical Center of Fudan Universitycollaborator
- First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
- Southwest Hospital, Chinacollaborator
- Qilu Hospital of Shandong Universitycollaborator
- Beijing Ditan Hospitalcollaborator
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schoolcollaborator
- Shandong Provincial Hospitalcollaborator
- Sichuan Provincial People's Hospitalcollaborator
- Huashan Hospitalcollaborator
- People's Hospital of Anshun City of Guizhou Provincecollaborator
- LanZhou Universitycollaborator
- General Hospital of Ningxia Medical Universitycollaborator
- Second Xiangya Hospital of Central South Universitycollaborator
- Chengdu Public Health Clinical Centercollaborator
- Ruijin Hospitalcollaborator
- Shanghai Jiao Tong University Affiliated Sixth People's Hospitalcollaborator
- Shandong First Medical Universitycollaborator
- The Second Hospital of Shandong Universitycollaborator
- Second Affiliated Hospital of Nanchang Universitycollaborator
- The Affiliated Hospital of Xuzhou Medical Universitycollaborator
- Hunan Provincial People's Hospitalcollaborator
- Zhengzhou University Affiliated Luoyang Centre Hospitalcollaborator
- Hebei Medical University Third Hospitalcollaborator
- The Second Hospital of Hebei Medical Universitycollaborator
- Hainan People's Hospitalcollaborator
- Zunyi Medical Collegecollaborator
- The Affiliated Hospital Of Guizhou Medical Universitycollaborator
- Second Affiliated Hospital of Guangzhou Medical Universitycollaborator
- People's Hospital of Guangxi Zhuang Autonomous Regioncollaborator
- First People's Hospital of Foshancollaborator
- First Affiliated Hospital of Fujian Medical Universitycollaborator
- Capital Medical Universitycollaborator
- Peking University People's Hospitalcollaborator
- Xiangya Hospital of Central South Universitycollaborator
- Shanghai Public Health Clinical Centrecollaborator
- The First Hospital of Jilin Universitycollaborator
- The First Hospital of Yunnan Provincecollaborator
- Shandong Provincial Clinical Center for Public Healthcollaborator
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
Study Sites (56)
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Nanfang Hospital
Guangzhou, Guangdong, 510515, 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
Biospecimen
blood, urine，stool
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jinjun Chen, Doctor
Nanfang Hospital, Sourthern Medical University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2021
First Posted
November 22, 2021
Study Start
September 15, 2021
Primary Completion
December 30, 2024
Study Completion (Estimated)
September 30, 2026
Last Updated
May 26, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share