NCT01440829

The Effectiveness of L-ornithine-L-aspartate (LOLA) on Plasma Ammonia in Cirrhotic Patients After TIPS

The Effectiveness of L-ornithine-L-aspartate on Plasma Ammonia in Cirrhotic Patients After TIPS Procedure: a Prospective, Randomized, Controlled, Open-label Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the effectiveness of L-ornithine-L-aspartate (LOLA) on plasma ammonia in cirrhotic patients after Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure.

Detailed description

Patients with successful TIPS deployment are randomized to LOLA arm and blank control arm. Plasma ammonia concentrations are measured before TIPS, day 1, day 4 and day 7 after TIPS.

Conditions

• Decompensated Cirrhosis
• Portal Hypertension
• Bleeding Varices
• Refractory Ascites

Interventions

Type	Name	Description
DRUG	L-ornithine-L-aspartate	The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-09-27
• Last updated: 2012-12-19

Locations

1 site across 1 country: China