Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in Acute on Chronic Liver Failure (ACLF)
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF. The main questions it aims to answer are: * Is the device safe when used according to the instructions for use? * Does the device work as expected by removing the excess of free iron from the blood? Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week.
• Male or female subjects ≥18 years and ≤80 years
• Subject is able to provide informed consent to participate in the study, otherwise written consent must be obtained on behalf of the subject by a next of kin or legal representative in accordance with local ethical and legal requirements
• History of an acute decompensation event (including but not limited to ascites, gastrointestinal bleeding, hepatic encephalopathy and/or acute bacterial infections), occurring within ≤6 weeks of screening
• Cirrhosis (diagnosed based on clinical, biological, morphological parameters or liver biopsy)
• Subject with:
‣ ACLF Grade 2, 3a or 3b based on the CLIF-C OF score
⁃ Under continuous renal replacement therapy (CRRT) or any organ support device that requires catheter placement