NCT05780190 Clinical Observation of CABA System in the Treatment of End-stage Liver Disease With Inflammation

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 40 participants in total. It began in 2023-03-10 with a primary completion date of 2027-10-10.

Brief Summary

End-stage liver disease (ESLD) refers to the late stage of liver disease caused by various chronic liver damage. ESLD is an important cause of global incidence rate and mortality, which has a significant impact on the health care system. ESLD is associated with various types of immune dysfunction. The artificial liver support system (ALSS) is an extracorporeal support system that temporarily and partially replaces the partial function of the liver. Its treatment mechanism is to remove all kinds of harmful substances, supplement essential substances, improve the internal environment, create conditions for hepatocyte regeneration and liver function recovery, or use it as a symptomatic support treatment method during the perioperative period of liver transplantation. In this study, we plan to use BS330 for plasma bilirubin adsorption. On this basis, we will add a CA280 cytokine adsorption column to establish a new artificial liver combination model CABA for the immune inflammatory damage mechanism of liver failure.

Eligibility Criteria

Inclusion Criteria: ① Age 18-70; ② Patients with end-stage liver disease, including patients with acute decompensation of cirrhosis, chronic liver failure and patients with chronic and acute liver failure in Child-Pugh grade B-C; A. Acute decompensation of liver cirrhosis: 1. ALB\<35 g/L; A / G \<1.0; 2. TBIL\> 120 μ mol / L; 3. ALT\> 1 × ULN and/or AST\>1 × ULN; 4. PTA \<60% 5. Ascites or hepatic encephalopathy or bleeding from esophageal varices; B. Chronic liver failure: 1. The basis of chronic liver disease: decompensated cirrhosis; 2. Time of onset: unlimited; 3. Hepatic encephalopathy: with or without; 4. Coagulation: PTA ≤ 40% or INR ≥ 1.5; 5. Jaundice\>171.1umol/L; C. Chronic plus acute liver failure: 1. Chronic liver disease is based on: chronic hepatitis or decompensated cirrhosis; 2. Time of onset:\<4 weeks; 3. Hepatic encephalopathy: with or without; 4. Coagulation: PTA ≤ 40% or INR ≥ 1.5; 5. Jaundice: TBIL ≥ 171 μ Mol/L or daily increase ≥ 17.1 μ mol/L ③ Inflammation status: the following 4 items meet any 2 items 1. PCT≥0.50 μ g/L 2. CRP≥40 mg/L 3. IL-6 \> 5 × ULN 4. IL-8 \> 5 × ULN ④ Understand and voluntarily sign the informed consent form approved by the Ethics Committee. Exclusion Criteria: * Patients with liver malignant tumor and other tumors; * People with HIV infection or other immunodeficiency diseases; * Pregnant or lactating women; * Patients with autoimmune disease, unstable stage of infarction caused by cardio-cerebrovascular accident, history of organ transplantation and other organ dysfunction or failure; ⑤ Patients with other serious complications (such as active bleeding, diffuse intravascular coagulation); ⑥ Those who are unable to return to the hospital for further consultation and follow-up regularly according to the research plan; * Those who fail to comply with the research arrangement and sign the informed consent form; ⑧ Other conditions judged by the researcher not suitable for the group.

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