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 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT01370161
Eligibility Criteria:
Inclusion Criteria:
* History of cirrhosis (clinical or by liver biopsy)
* Admission due to acute bleeding from oesophageal or gastric (GOV1 or GOV2) varices
* Child-Pugh Class C (Child-Pugh score less than or equal to 13) or Child-Pugh class B
* Signed written informed consent
Exclusion Criteria:
* Patients not fulfilling inclusion criteria
* Pregnancy or breast-feeding
* Confirmed hepatocellular carcinoma
* Creatinine greater than 3 mg/dl
* Terminal hepatic failure (Child-Pugh score greater than 13)
* Previous treatment with TIPS or combined pharmacological and endoscopic treatment to prevent rebleeding
* Fundal or ectopic gastric variceal bleeding (IGV1 or IGV2)
* Complete portal vein thrombosis or portal cavernoma
* Congestive heart failure New York Heart Association (NYHA) greater than III or medical history of pulmonary hypertension
* Spontaneous recurrent hepatic encephalopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01370161
Study Brief:
Protocol Section:
NCT01370161