Status:
UNKNOWN
Establishment and Assessment of the HVPG Using Biofluid Mechanics (HVPGBFM)
Lead Sponsor:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborating Sponsors:
RenJi Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Liver Cirrhosis
Hypertension, Portal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a prospective, non-controlled, multicentre trial in patients with cirrhosis or portal hypertension. In this study, the investigators aim to establish the HVPG using biofluid mechanics (H...
Detailed Description
Consecutive patients are randomly assigned 1:1 to either the original cohort or the validation cohort. Randomization is based on the computer-generated random digits table. This study consists of two ...
Eligibility Criteria
Inclusion
- Be at least 18 years of age.
- Patients with cirrhosis or portal hypertension, scheduled for HVPG measurement.
Exclusion
- Female patients who are pregnant or nursing.
- Patients who are medically unstable, terminally or seriously ill, or patients whose clinical course is unpredictable.
- Patients with clinically unstable cardiac disease, for example: congenital heart defect, arrhythmia, uncontrolled heart failure (NYHA Class IV).
- Patients with respiratory distress syndrome or clinically unstable pulmonary disease, for example: pulmonary hypertension, pulmonary emboli, pulmonary vasculitis, emphysema.
- Patients with severe coagulation disorders.
- Patients with unstable occlusive disease or thrombosis within the hepatic, portal, or mesenteric veins.
- Patients who are allergic to iodinated contrast.
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03470389
Start Date
March 20 2018
End Date
September 1 2020
Last Update
December 14 2018
Active Locations (1)
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1
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200011