Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2025-12-29 @ 12:22 AM
Study NCT ID:
NCT07178366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Sponsor:
Institute of Liver and Biliary Sciences, India
Organization:
Study Overview
Official Title:
Impact of Double Plasma Separation and Adsorption on Patients With Acute on Chronic Liver Failure- A Prospective Open-label Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
DPMAS-ACLF
Brief Summary:
Acute-on-chronic liver failure (ACLF) is a serious condition in which patients with chronic liver disease suddenly develop severe liver injury, leading to inflammation, organ failure, and very high short-term mortality. Standard medical treatment can help, but many patients still do poorly without liver transplantation.
This study will test whether Double Plasma Molecular Adsorption System (DPMAS), an extracorporeal blood purification therapy, can improve outcomes in ACLF patients. DPMAS works by filtering the blood through special adsorption columns that remove harmful substances such as bile acids, toxins, and inflammatory molecules.
In this randomized controlled trial, adult patients with ACLF will be randomly assigned to receive either:
Standard medical therapy alone, or
Standard medical therapy plus DPMAS.
The main goal is to see whether DPMAS can improve liver function and reduce disease severity within 14 days. Other outcomes include survival without liver transplant at 28 days, improvement in organ functions, reduction in inflammation, and safety of the procedure.
The study will be conducted at the Institute of Liver and Biliary Sciences (ILBS), New Delhi, India, and will enroll about 56 participants over one year.
This study will test whether Double Plasma Molecular Adsorption System (DPMAS), an extracorporeal blood purification therapy, can improve outcomes in ACLF patients. DPMAS works by filtering the blood through special adsorption columns that remove harmful substances such as bile acids, toxins, and inflammatory molecules.
In this randomized controlled trial, adult patients with ACLF will be randomly assigned to receive either:
Standard medical therapy alone, or
Standard medical therapy plus DPMAS.
The main goal is to see whether DPMAS can improve liver function and reduce disease severity within 14 days. Other outcomes include survival without liver transplant at 28 days, improvement in organ functions, reduction in inflammation, and safety of the procedure.
The study will be conducted at the Institute of Liver and Biliary Sciences (ILBS), New Delhi, India, and will enroll about 56 participants over one year.
Detailed Description:
Acute-on-chronic liver failure (ACLF) is characterized by acute deterioration of liver function in patients with chronic liver disease, leading to systemic inflammation, organ failure, and high short-term mortality. Current treatment is largely supportive, and liver transplantation is often the only curative option, but many patients are not eligible or die while awaiting transplant.
Recent evidence suggests that systemic inflammation, bile acid accumulation, and damage-associated molecular patterns (DAMPs) play key roles in the progression of ACLF. Extracorporeal liver support systems such as plasma exchange have shown benefit in selected patients by reducing inflammation and improving short-term survival.
The Double Plasma Molecular Adsorption System (DPMAS) is a novel extracorporeal therapy that combines plasma separation with sequential adsorption columns. These columns are designed to remove bile acids, bilirubin, cytokines, and other toxins from the circulation. Early studies suggest that DPMAS may improve organ function and reduce mortality in ACLF.
This prospective, open-label, randomized controlled trial will compare standard medical therapy (SMT) alone versus SMT plus DPMAS in adult patients with ACLF (AARC grade II or higher). The primary outcome is an improvement in AARC grade by 1 at day 14 (7 days off treatment). Secondary outcomes include transplant-free survival at 28 days, changes in systemic inflammation, renal and hemodynamic function, bilirubin and bile acid levels, development of infections or new organ failures, and safety of the therapy.
A total of 56 participants will be enrolled and randomized equally into the two study groups. Patients in the intervention arm will undergo a minimum of two DPMAS sessions within the first seven days, with additional sessions as clinically indicated. Participants will be followed for up to 90 days for survival and clinical outcomes.
The study is investigator-initiated and conducted at the Institute of Liver and Biliary Sciences (ILBS), New Delhi, India. Ethical approval has been obtained from the ILBS Institutional Ethics Committee.
Recent evidence suggests that systemic inflammation, bile acid accumulation, and damage-associated molecular patterns (DAMPs) play key roles in the progression of ACLF. Extracorporeal liver support systems such as plasma exchange have shown benefit in selected patients by reducing inflammation and improving short-term survival.
The Double Plasma Molecular Adsorption System (DPMAS) is a novel extracorporeal therapy that combines plasma separation with sequential adsorption columns. These columns are designed to remove bile acids, bilirubin, cytokines, and other toxins from the circulation. Early studies suggest that DPMAS may improve organ function and reduce mortality in ACLF.
This prospective, open-label, randomized controlled trial will compare standard medical therapy (SMT) alone versus SMT plus DPMAS in adult patients with ACLF (AARC grade II or higher). The primary outcome is an improvement in AARC grade by 1 at day 14 (7 days off treatment). Secondary outcomes include transplant-free survival at 28 days, changes in systemic inflammation, renal and hemodynamic function, bilirubin and bile acid levels, development of infections or new organ failures, and safety of the therapy.
A total of 56 participants will be enrolled and randomized equally into the two study groups. Patients in the intervention arm will undergo a minimum of two DPMAS sessions within the first seven days, with additional sessions as clinically indicated. Participants will be followed for up to 90 days for survival and clinical outcomes.
The study is investigator-initiated and conducted at the Institute of Liver and Biliary Sciences (ILBS), New Delhi, India. Ethical approval has been obtained from the ILBS Institutional Ethics Committee.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IEC Approval Number | OTHER | Institute of Liver and Biliary Sciences (ILBS) | View |