Profiling liver disease patients using DPMAS therapy
Precise Profiling of Liver Disease Patients With DPMAS Therapy, Treating Optimal Patients and Achieving Hard Endpoint: a Multicenter, Cluster-controlled Study (PADSTONE Study)
This study is testing if a new treatment called DPMAS can help hospitalized patients with severe liver problems live longer and manage their organ failures better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05129904 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with acute-on-chronic liver failure (ACLF) who are hospitalized and have chronic liver disease. It investigates the efficacy of the double plasma molecular absorption system (DPMAS), an extracorporeal treatment that aims to cleanse toxic plasma in patients with severe liver conditions. The study will assess the outcomes of DPMAS therapy in improving patient survival and managing organ failures associated with ACLF. The research aims to identify optimal candidates for this therapy and evaluate its effectiveness compared to traditional treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized patients over 18 years old with chronic liver disease and elevated bilirubin levels.
Not a fit: Patients with more than three organ failures or severe non-hepatic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve survival rates and quality of life for patients suffering from acute-on-chronic liver failure.
How similar studies have performed: While there have been studies on extracorporeal liver support, the specific application of DPMAS therapy in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Hospitalized patients 2. Age \>18 years 3. Chronic liver disease regardless of the etiology 4. Total bilirubin ≥ 12mg/dl and INR ≥ 1.5 Exclusion Criteria: 1. with more than three organ failures (SOFA 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.
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Jinjun Chen, Doctor
- Email: chjj@smu.edu.cn
- Phone: 18588531001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.