Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377774
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-14
Brief Title:
To Optimize Therapeutic Procedures of DPMAS in ACLF Patients a Prospective Sigle Arm and Multicenter Study
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
To Optimize Therapeutic Procedures of Double-plasma Molecular Absorption System Therapy in acute-on Chronic Liver Failure Patients a Prospective Sigle Arm and Multicenter Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 profilesbiomarkers of the indication of DPMAS treatment
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 profilesbiomarkers of the indication of DPMAS treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None