NCT03084185

Evaluation of the Role of Plasma Biomarkers in the Development of Decompensation in Patients With Cirrhosis .

Evaluation of the Role of Plasma Biomarkers for Portal Hypertension Progression and Oxidative Damage in Decompensation of Cirrhotic Patient.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University of Modena and Reggio Emilia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center and prospective study to identify specific biomarker in order to predict development of decompensation in cirrhotic patients. The duration of the study is 36 months and it provides a cohort of 200 patients.

Detailed description

At screening, patient will have taken blood samples and performed hepatic vein pressure gradient. After randomization, patient will be seen at follow up every 3 months to do blood sample and every 12 months to undergo hepatic vein pressure gradient , according to the guidelines. In addition, metabolomics analysis will be performed at screening and every 3 months. The results will be analyzed in relation to emergence of decompensation during follow up period, in order to identify specific metabolomics characteristics that may be able to predict decompensation.

Conditions

• Cirrhosis

Timeline

• Start date: 2012-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-03-20
• Last updated: 2017-09-13

Locations

1 site across 1 country: Italy