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Tests treatment safety and results for Acute-On-Chronic Liver Failure
Official title Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis
ClinicalTrials.gov ID: NCT06562803
What this study is testing
- What it's testing
- This study aims to evaluate the efficacy and safety of the double plasma cytokine adsorption system with sequential low-dose plasma exchange (DPCAS+LPE) in patients with acute-on-chronic liver failure (ACLF) complicated by sepsis. The focus is on assessing the impact of the cytokine adsorption column(CA280,Jafron Biomedical Co., Ltd., Zhuhai, China) on survival rates, inflammation markers, and organ function to determine its potential value in clinical practice.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age between 18 and 70 years with a background of chronic liver disease, regardless of the presence of cirrhosis.
- Total bilirubin (TBIL) \> 12 mg/dL.
- International normalized ratio (INR) ≥ 1.5.
- Meeting the diagnostic criteria for sepsis: confirmed or suspected infection, with a sequential organ failure assessment (SOFA) score increase of ≥ 2...
You likely can't join if
- Inherited metabolic liver disease (including Wilson's disease, hereditary hemochromatosis, and alpha-1 antitrypsin deficiency).
- Patients with hepatocellular carcinoma or other malignancies.
- Pregnant or breastfeeding women.
- Patients with human immunodeficiency virus (HIV) infection or other immunodeficiency diseases (including active hematological malignancies...
- Unstable phase of cerebrovascular events.
- History of organ transplantation.
See the full eligibility criteria
- Age between 18 and 70 years with a background of chronic liver disease, regardless of the presence of cirrhosis.
- Total bilirubin (TBIL) \> 12 mg/dL.
- International normalized ratio (INR) ≥ 1.5.
- Meeting the diagnostic criteria for sepsis: confirmed or suspected infection, with a sequential organ failure assessment (SOFA) score increase of ≥ 2 points. (5) High inflammatory status: IL-6 \> 80 pg/ml. (6) Diagnosis...
- Inherited metabolic liver disease (including Wilson's disease, hereditary hemochromatosis, and alpha-1 antitrypsin deficiency).
- Patients with hepatocellular carcinoma or other malignancies.
- Pregnant or breastfeeding women.
- Patients with human immunodeficiency virus (HIV) infection or other immunodeficiency diseases (including active hematological malignancies, congenital immunodeficiency syndromes, or those currently receiving high-dose...
- Unstable phase of cerebrovascular events.
- History of organ transplantation.
- Patients with irreversible or terminal extrahepatic organ failure that precludes safe extracorporeal circulation or confounds the intervention: ①Terminal chronic obstructive pulmonary disease, terminal cor pulmonale...
- Platelet count \ 3.5), or active bleeding.
- Known allergies to extracorporeal circulation, hemoperfusion, or other severe allergic history.
- Refusal by the patient or their legally authorized representative (LAR) to participate in the study, or sign the informed consent form.
- Inability to return for regular follow-up visits as planned in the study.
- Other conditions that, in the judgment of the researchers, make the patient unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.