Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy

University of Roma La Sapienza

Status and phase: Completed; Phase 4

Conditions: Hepatic Encephalopathy

Treatments: Drug: Albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT01559519

2012-000931-20

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of albumin infusion to prevent post tips hepatic encephalopathy'

Full description

The outcome is the prevention of post tips hepatic encephalopathy

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cirrhotic patients
• TIPS placement
• Absence of Hepatic Encephalopathy at the enrolement
• Age > 18 years
• No pregnancy

Exclusion criteria

• Non-cirrhotic portal hypertension
• Previous liver transplantation
• Impossibility to attend the scheduled follow-up including the weekly visit as outpatients during the first month after TIPS (see the description of follow-up below)
• Sings of overt hepatic encephalopathy as well as a history of persistent HE at entry. The latter as a contraindication for TIPS placement

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

albumin

Active Comparator group

Description:

cirrhotic patients who underwent tips placement

Treatment:

Drug: Albumin