跳至主要内容
临床试验/EUCTR2014-004809-33-ES
EUCTR2014-004809-33-ES进行中(未招募)1 期

Albumin infusion effects in patients with cirrhosis hepatic encephalopathy

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)0 个研究点目标入组 140 人开始时间: 2015年1月12日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
140

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Age between 18 and 85 years.
  • 2. Liver cirrhosis defined by previous clinical data or liver biopsy.
  • 3. Presence of an episode of acute hepatic encephalopathy of grade> 2.
  • 4. Sign the informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 140
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 140

排除标准

  • 1. Pregnant or breast-feeding.
  • 2. Terminal illness.
  • 3. Presence of Acute-on-chronic liver failure.
  • 4. Needing for intensive support measures.
  • 5. Active gastrointestinal bleeding.
  • 6. neurological or psychiatric comorbidity that hinders the assessment of hepatic encephalopathy.
  • 7. Clinical situations in which it is contraindicated to administer intravenous albumin.
  • 8. MELD score less than 15 or greater than 25 at the time of inclusion
  • 9. Any medical condition previous to patient inclusion in the study involving administration of albumin during a previous 7 day period.

研究者

发起方
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

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