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 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT03493204
Eligibility Criteria:
Inclusion Criteria:
* Adult 18 years or older of age
* Clinical diagnosis of cirrhosis with ascites. Diagnosis of cirrhosis will be based upon:
1. liver biopsy, OR
2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
3. 2 of the following 4 criteria: i. Ultrasound (US), computerized axial tomography (CT) or Magnetic Resonance Imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites) ii. Fibroscan liver stiffness score \>13 kPa iii. Laboratory testing: Aspartate Aminotransferase (AST)/platelet ratio index (APRI) \>2.0 iv. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
* 3\) At least one of the following: Any cause hospitalization within 90 days OR outpatient therapeutic paracentesis within 30 days
Exclusion Criteria:
* Language barriers that cannot be surmounted with in-person interpreters
* Estimated life expectancy \< 3 months
* Pregnancy (self-reported)
* Unable or unwilling to provide consent
* History of liver transplant
* Planned discharge to nursing facility
* Anuria or serum creatinine \> 2.0 mg/dL
* Uncontrolled hepatic encephalopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03493204
Study Brief:
Protocol Section:
NCT03493204