Precise Profiling of Liver Disease Patients With DPMAS Therapy, Treating Optimal Patients and Achieving Hard Endpoint (PADSTONE Study)
NCT ID: NCT05129904
Last Updated: 2023-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1300 participants
OBSERVATIONAL
2021-09-15
2024-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Double plasma molecular absorption system treatment
Patients treat with DPMAS alone or in combination with plasma exchange
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
Standard medical therapy
Patients with standard medical therapy except for DPMAS treatment or other artificial liver support system
No interventions assigned to this group
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \>18 years
3. Chronic liver disease regardless of the etiology
4. Total bilirubin ≥ 12mg/dl and INR ≥ 1.5
Exclusion Criteria
2. the pregnant;
3. 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); 4) human immunodeficiency virus (HIV) infection without treatment;
5\) patients with unstable hemodynamics caused by infection or acute bleeding; 6) hospital stays \<48 hours; 7) diagnosis of hepatocellular carcinoma during screening period; 8) for the DPMAS clusters: patients unwilling to receive DPMAS treatment alone or in combination with PE; 9) for the SMT clusters: patients plan to receive DPMAS therapy or other ALSS; 10) not suitable to participate in this study judging by researchers; 11) not sign the informed consent.
18 Years
80 Years
ALL
No
Sponsors
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Xiangya Hospital of Central South University
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Tianjin Third Central Hospital
OTHER
Henan Provincial People's Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Beijing YouAn Hospital
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
West China Hospital
OTHER
The Second Affiliated Hospital of Kunming Medical University
OTHER
Meng Chao Hepatobiliary Hospital of Fujian Medical University
OTHER
The Second Affiliated Hospital of Chongqing Medical University
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
The Ninth Hospital of Nanchang
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
The First Affiliated Hospital of Shanxi Medical University
OTHER
Taihe Hospital
OTHER
Beijing 302 Hospital
OTHER
Shanghai Public Health Clinical Center of Fudan University
UNKNOWN
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Southwest Hospital, China
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Qilu Hospital of Shandong University
OTHER
Beijing Ditan Hospital
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Shanghai Public Health Clinical Center
OTHER_GOV
Shandong Provincial Hospital
OTHER_GOV
The First Hospital of Jilin University
OTHER
Sichuan Provincial People's Hospital
OTHER
Huashan Hospital
OTHER
People's Hospital of Anshun City of Guizhou Province
OTHER
LanZhou University
OTHER
General Hospital of Ningxia Medical University
OTHER
Second Xiangya Hospital of Central South University
OTHER
The First Hospital of Yunnan Province
UNKNOWN
Chengdu Public Health Clinical Center
UNKNOWN
Ruijin Hospital
OTHER
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
OTHER
Shandong Provincial Clinical Center for Public Health
UNKNOWN
Shandong First Medical University
OTHER
The Second Hospital of Shandong University
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
Hunan Provincial People's Hospital
OTHER
Union Hospital, Tongji Medical College
UNKNOWN
Zhengzhou University Affiliated Luoyang Centre Hospital
UNKNOWN
Hebei Medical University Third Hospital
OTHER
The Second Hospital of Hebei Medical University
OTHER
Hainan People's Hospital
OTHER
Zunyi Medical College
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
UNKNOWN
People's Hospital of Guangxi Zhuang Autonomous Region
OTHER
First People's Hospital of Foshan
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
Capital Medical University
OTHER
Peking University People's Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Jinjun Chen
Professor
Principal Investigators
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Jinjun Chen, Doctor
Role: STUDY_DIRECTOR
Nanfang Hospital, Sourthern Medical University
Locations
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Nanfang Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Jinjun Chen
Role: primary
Other Identifiers
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NFEC-2021-259
Identifier Type: -
Identifier Source: org_study_id
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