Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
NCT ID:
NCT03585257
Eligibility Criteria:
Inclusion Criteria:
1. Age \>18 years
2. Cirrhosis defined by any one of the following
1. Cirrhosis on liver biopsy or transient wave elastography
2. Nodular liver on imaging
3. Endoscopic or radiological evidence of varices in a patient with chronic liver disease
4. Platelet count \<150,000/mm3 and AST/ALT ratio \>1 in a patient with chronic liver disease
5. Patients with frank decompensation (ascites, HE, variceal bleeding, hepato-pulmonary syndrome)
3. Prior HE controlled on standard of care therapy defined as lactulose or rifaximin for at least 2 months prior to enrollment.
4. Serum albumin \<4 gm/dl
5. Cognitive impairment on any of the three testing strategies for HE including Psychometric hepatic encephalopathy score (PHES), Stroop test and Critical Flicker Frequency
1. PHES aggregate score \<-4SD based on norms published in Allampati et al located at the website www.encephalapp.com
2. Stroop OffTime+OnTime values greater than norms published in Allampati et al located at the website www.encephalapp.com
3. Critical Flicker Frequency value \<39 Hz
Exclusion Criteria:
1. Unclear diagnosis of cirrhosis (does not meet the criteria outlined above)
2. No prior overt HE episodes
3. HE uncontrolled on standard of care defined as a mini-mental status exam\<25
4. On regular IV albumin infusions due to scheduled paracentesis within the last 3 months
5. Recent alcohol abuse (within 3 months)
6. Unable to give consent
7. Current or recent invasive bacterial or fungal infections (\<1 month)
8. Allergic reactions to IV albumin
9. Current or recent congestive heart failure (Systolic ejection fraction \<25%) within the last year
10. Pregnancy (positive urine pregnancy test at screening)
11. In the opinion of the PI, those who are unlikely to survive 6 weeks or be able to adhere to the trial activities.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03585257
Study Brief:
Protocol Section:
NCT03585257