The Effectiveness of L-ornithine-L-aspartate (LOLA) on Plasma Ammonia in Cirrhotic Patients After TIPS
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effectiveness of L-ornithine-L-aspartate on Plasma Ammonia in Cirrhotic Patients After TIPS Procedure: a Prospective, Randomized, Controlled, Open-label Clinical Trial|
- Plasma ammonia [ Time Frame: One week ] [ Designated as safety issue: No ]The plasma ammonia concentrations of venous blood at the first, fourth and seventh days after TIPS procedure.
- Incidence of hepatic encephalopathy [ Time Frame: One week ] [ Designated as safety issue: No ]
- Liver function [ Time Frame: One week ] [ Designated as safety issue: No ]The liver function (includes PT/INR, APTT, albumin, bilirubin, Child-Pugh score) at the first, fourth and seventh days after TIPS procedure.
- Psychometric tests [ Time Frame: One week ] [ Designated as safety issue: No ]The results of the psychometric tests (include number connection test A, number connection test B, digit symbol test, serial dotting test, line tracing test) at the first, fourth and seventh days after TIPS procedure.
|Study Start Date:||December 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: LOLA group
Intervention: LOLA (30g per day) for a week.
The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.
No Intervention: Control group
Patients will not be treated with LOLA.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440829
|Xijing Hospital of Digestive Diseases, Fourth Military Medical University|
|Xi`an, Shaanxi, China, 710032|
|Principal Investigator:||Guohong Han, PhD & MD||Xijing Hospital of Digestive Diseases, Fourth Military Medical University|