An observational study in Acute-On-Chronic Liver Failure, sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Nanfang Hospital, Southern Medical University · Observational
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Acute-on-chronic liver failure (ACLF) is a life-threaten syndrome carrying high-short-term mortality raging 40% to 60% within 90 days in patients with chronic liver disease. Double plasma molecular adsorption system (DPMAS) is one of the available artificial liver support systems, which combines plasma filtration and two specific adsorption membranes dedicating to remove bilirubin and the middle molecular toxins respectively. The efficiency of DMPAS treatment in liver failure patients remains controversial. Previous study indicate that liver failure patients with DPMAS therapy improve the short-term mortality and prevent the diseases progression within 28 days (PADSTONE Study). Thus, this single-arm, multicenter and prospective study is to further validate and optimize the therapeutic procedures of DPMAS therapy in ACLF patients.
Liver failure in patients with chronic liver disease (CLD) and carries high short-term mortality ranging 40% to 60% within 90 days. In China Mainland, chronic hepatitis B virus (HBV) infection is the most common etiology of liver failure in CLD patients which reveals histological signature with submissive hepatic necrosis. While liver transplantation (LT) remains the treatment of choice, the lack of organ transplants necessitates finding alternative solutions. Supportive therapy including cardiovascular or renal support, treatment of encephalopathy and extracorporeal liver support, are the available treatments for liver failure patients in the clinical practice.
Artificial liver support system (ALSS) can remove inflammatory cytokines and toxins which is commonly used in clinical practice to treat liver failure. Double plasma molecular adsorption system (DPMAS) which is one of the ALSS combines plasma filtration and two specific adsorption membranes which can effectively remove bilirubin and the middle molecular toxins respectively. Within the last years, DPMAS is developed to one of the most recent non-biological extracorporeal liver support devices that used in acute or acute-on-chronic liver failure (ACLF) patients. In the clinical practice, DPMAS therapy in liver failure patients usually combines with therapeutic plasma exchange (PE). Previous investigations suggested that DPMAS and therapeutic PE were similar in improving 90-day survivals and DPMAS together with PE ameliorated the inflammatory response and improved the 28-day survival in HBV related ACLF.
However, the efficiency of DMPAS treatment in liver failure patients remains controversial and no large scale study to explore the potential subgroup of liver failure patients with chronic liver disease that may benefit from DPMAS therapy at present. Our previous study (PADSTONE Study) indicate that DPMAS therapy may improve the short-term mortality and prevent the disease progression in ACLF patients which needs to be further validated.
Accordingly, this single-arm study will enroll the ACLF patients with DPMAS therapy and aim to optimize and validate the therapeutic procedures of the DPMAS therapy in ACLF patients. Biological-samples will be collected in this study including plasma, urine and stools and multi-omics will be performed to explore and validate the precise profiles/biomarkers of the indication of DPMAS treatment.
167 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 62 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 235 across 65 observational studies indexed under Acute-On-Chronic Liver Failure.
Browse Acute-On-Chronic Liver Failure studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study focus on acute-on-chronic liver failure (ACLF) patients which carries high prevalence and short-term mortality. ACLF patients are featured by multiple organ failure. Except for liver transplantation, the routine use of artificial or bioartifical extracorporeal liver support or plasma exchange appears to be a promising and effective bridging therapy in patients with ACLF to liver transplantation or spontaneous regeneration.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a prosepctive, sigle-arm and muticenter study. The study will enroll ACLF patients which receive the DPMAS therpay during hospitalization.
Other: No intervention in this study
No intervention in this study
28-day transplantation-free mortality
Comparing to the PADSTONE study, the 28-day transplantation-free mortality in ACLF patients with DPMAS therapy.
Time frame: 28 days
The disease progression rate
Comparing to the PADSTONE study, the disease progression (progress to EASL defined ACLF) rate within 28 days.
Time frame: 28 days
the 90-day transplantation-free mortality
Comparing to the PADSTONE study, the 90-day transplantation-free mortality in ACLF patients with DPMAS therapy.
Time frame: 90 days
the disease progression
Comparing to the PADSTONE study, the disease progression (progress to EASL defined ACLF) rate within 90 days
Time frame: 90 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2024; primary completion for Mar 2025, 10 months later.
Of 38 observational studies under Acute-On-Chronic Liver Failure, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Acute-On-Chronic Liver Failure →
Nanfang Hospital, Southern Medical University →