Portal Hypertension Clinical Trial
— NEPTUN2Official title:
Non-invasive Evaluation of Prognostic Parameters for Patients With Transjugular Intrahepatic Portosystemic Shunt (TIPS) Using a Structured Follow up Protocol 2
NCT number | NCT04393519 |
Other study ID # | NEPTUN2 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 12, 2020 |
Est. completion date | December 31, 2030 |
Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Insertion of TIPS according to guidelines Exclusion Criteria: - Contraindication for TIPS |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Bonn | Bonn |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bonn |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival | death, liver transplantation | up to 10 years | |
Secondary | Ascites | Evaluation of amount of ascites according to the Child-Score (0=none;1=moderate/treatable; 2=severe/refractory) | up to 10 years | |
Secondary | Hepatic Encephalopathy (HE) | Evaluation of the grade according to the West Haven Criteria (Grade 0 (no HE) - Grade 4 (hepatic coma)) | up to 10 years | |
Secondary | Variceal Bleeding | Assessment of presence of variceal bleeding | up to 10 years | |
Secondary | Liver Failure | defined as Bilirubin level = 12mg/dl | up to 10 years | |
Secondary | Acute-on-Chronic Liver Failure (ACLF) | Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria | up to 10 years | |
Secondary | Organ Failures | Assessment of Organ failures according to CLIF-Sequential Organ Failure Assessment (SOFA) Score (Score 6 (best) to 18 (worst)) | up to 10 years | |
Secondary | Kidney Failure | Assessment of AKI according to KDIGO definition | up to 10 years | |
Secondary | Sarcopenia | Assessment of sarcopenia according to EASL-guideline definition | up to 10 years | |
Secondary | post-surgical survival | Assessment of post-surgical survival | up to 10 years |
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