An Open-label Randomized Controlled Trial Comparing the Role of Therapeutic Plasma-exchange in Ameliorating Secondary Organ Dysfunctions in Patients With ACLF and Develop Biomarkers of Treatment Response

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a treatment called plasma exchange can help patients with Acute on Chronic Liver Failure (ACLF) by reducing complications related to other organs. ACLF can lead to severe inflammation and problems in multiple organs, which can be life-threatening. The study aims to see if plasma exchange can improve outcomes for these patients and identify specific markers that can help doctors understand how well the treatment is working.

To participate in this trial, patients must be between 18 and 65 years old and diagnosed with ACLF that is moderately severe or worse. They should also have at least one organ failure. Unfortunately, individuals with certain conditions, such as severe bleeding, active cancers, or significant heart or kidney disease, will not be eligible. If someone is part of the trial, they can expect close monitoring and support throughout the study. This research is important as it hopes to provide new insights into treating ACLF and improving patient care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with ACLF with AARC grade 2 or more with or without single secondary organ failure.
• Exclusion Criteria:
• • 1. 1. Patients with age less than 18 years or more than 65 years
• • 2. Patients with HVOTO or EHPVO
• • 3. Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy
• • 4. Active bleed (mucosal or variceal) or severe coagulopathy (platelets \<20,000 or INR\>4)
• • 5. Patients with refractory shock requiring norepinephrine \>0.5ug/kg/min
• • 6. Patients with retroviral infections
• • 7. Pregnancy or active breastfeeding
• • 8. Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease)
• • 9. Lack of informed consent