To Optimize Therapeutic Procedures of DPMAS in ACLF Patients: a Prospective, Sigle Arm and Multicenter Study

NCT06377774 | Not Yet Recruiting DMC

• 1 other identifier: NFEC-2024-096
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute-On-Chronic Liver Failure

Keywords

double plasma molecular adsorption system; acute-on-chronic liver failure; short-term mortality

Outcome Measures

Primary Outcomes (2)

• 28-day transplantation-free mortality

  Comparing to the PADSTONE study, the 28-day transplantation-free mortality in ACLF patients with DPMAS therapy.

  28 days

• The disease progression rate

  Comparing to the PADSTONE study, the disease progression (progress to EASL defined ACLF) rate within 28 days.

  28 days

Secondary Outcomes (2)

• the 90-day transplantation-free mortality

  90 days

• the disease progression

  90 days

Study Arms (1)

DPMAS therapy group

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

Interventions

No intervention in this study OTHER

No intervention in this study

DPMAS therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Sign the informed consent voluntarily;
• Age\>18 years old;
• Inpatients;
• Chronic liver disease;
• The value of total bilirubin≥12mg/dl and INR≥1.5;
• Patients are planned to have DPMAS therapy according to the physicians' judgment.

You may not qualify if:

• The pregnant;
• With severe chronic heart disease (NYHA\>II);
• With severe chronic obstructive pulmonary disease (GOLD\>III);
• With serious mental illness that prevents patients from sell-reporting;
• Patients with unstable hemodynamics caused by infection or acute bleeding;
• Diagnosis of hepatocellular carcinoma during screening period (BCLC\>B);
• With severe extrahepatic malignant carcinoma;
• Patients who had liver resection or other organ transplantation;
• Patients who had participated in, or are planning to participate in other clinical trial within the 3 months prior to enrollment;
• Hospital stays \<48 hours;
• Not suitable to participate in this study judging by researchers;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Biospecimen

Retention: SAMPLES WITH DNA

The study will collect biological-samples including whole blood, urine and stool.

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Jinjun Chen, Dr.

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beiling Li, Dr

CONTACT

+8613570541527; 820584791@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 22, 2024
• Study Start: May 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: February 1, 2026
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share