NCT04975490

Characterization and Pathogenesis of ACLF

Beobachtungsstudie für Die Charakterisierung Der Pathogenese Des Akut-auf-chronischen Leberversagens

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This single-center prospective observational study aims at characterization of pathogenesis of ACLF. There will be three different cohorts investigated with the main endpoint mortality in these groups. 1. SAPIENT = Sepsis ACLF patients, to investigate the differences between ACLF and sepsis in cirrhosis 2. PROACT = Portal mediators as ACLF Targets, to assess portal venous biomarkers in patients receiving TIPS leading to ACLF and identify potential treatment targets 3. ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts, to assess in ACLF-patients receiving liver transplantation predictors of survival, which may improve selection of ACLF-patients for liver transplantation Secondary endpoints will be different in the three different cohorts and biological material will be collected for separate ancillary studies.

Conditions

• Liver Cirrhosis
• Acute-On-Chronic Liver Failure
• Portal Hypertension

Timeline

• Start date: 2020-12-01
• Primary completion: 2025-09-30
• Completion: 2025-12-31
• First posted: 2021-07-23
• Last updated: 2021-07-29

Locations

1 site across 1 country: Germany