NCT04664621撤回不适用
HepQuant to Predict Hepatic Encephalopathy in Patients Who Receive Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Refractory Ascites - a Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Onset of Hepatic Encephalopathy
研究概览
简要总结
A pilot study to determine if a simple blood test can predict patients at risk for significant episodes of confusion and disorientation that can occur in patients who receive an artificial shunt through the liver to control complications of liver disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects over the age of 18 able to provide consent
- •Subjects undergoing initial TIPS procedure for the primary indication of treatment of ascites
排除标准
- •Prisoners
- •Pregnant women
- •Subjects undergoing TIPS placement as part of an investigational study outside of usual clinical care
- •Subjects taking beta-blocker medications or angiotensin converting enzyme inhibitors
- •Subjects with evidence of porto-systemic shunts present on imaging (eg splenorenal shunt)
- •Subjects with calculated MELD score >12 based on most recent laboratory values before consent
- •Subjects with prior history of overt hepatic encephalopathy (grade 3-4) that was primary reason for hospitalization. Episodes of hepatic encephalopathy that were the consequence of other precipitating event (such as variceal bleeding or infection) will not be considered exclusionary.
- •Subjects with a known sensitivity to albumin preparations, any ingredient in the formulation, or components of the container
- •Subjects unable to fast for >5 hours prior to the HepQuant administration or subjects who are unable to drink the oral dose of the cholate (~40mL of liquid).
结局指标
主要结局
Onset of Hepatic Encephalopathy
时间窗: 6 months
次要结局
未报告次要终点
研究者
Justin Boike
Assistant Professor of Medicine
Northwestern University
研究点 (2)
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