This study examines the effects of plasma exchange (PE) using human serum albumin 5% in people with acute-on-chronic liver failure (ACLF). ACLF is a worsening of liver function in someone with existing liver disease. The study is conducted across 40 centers in the US, Canada, and Europe. Participants will be randomly assigned into two groups: one receiving standard medical treatment (SMT) with PE, and the other receiving SMT alone. The treatment varies from 7 to 17 days based on each person's condition, followed by a 90-day follow-up.
The study includes about 380 patients aged 18-79 with cirrhosis and a high risk of hospital mortality. Patients must agree to participate, or a representative will give consent if they are unable.
- The study lasts up to 107 days, including treatment and follow-up.
- Participants must visit the study site for treatment and monitoring.
- Safety is closely monitored by a special board throughout the study.
Before joining, patients must meet specific criteria and shouldn't have certain conditions like severe infections or recent participation in another study.