Cirrhotic and Non-cirrhotic Patients With Clinically Significant Portal Hypertension

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT07405749
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Cirrhosis, Liver
  • Clinically Significant Portal Hypertension(CSPH)
  • Gastroesophageal Varices
  • Portal Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

Alterations in conventional coagulation tests in patients with cirrhosis and/or portal hypertension do not reliably predict bleeding risk, as hemostatic balance is complex and often compensated. Many procedure-related bleeding events are driven by non-coagulatory factors, such as portal hypertension or technical aspects of the procedure. Most commonly performed procedures carry a low risk of bleeding even in the presence of elevated INR or thrombocytopenia, and no validated laboratory thresholds support prophylactic correction. Risk assessment should therefore be based on procedural factors, severity of liver disease, and systemic patient conditions, with correction of modifiable risk factors particularly before high-risk elective procedures.

Key Dates

First listed
Feb 12, 2026
Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
2,500 participants (estimated)

Primary Outcome Measure

Incidence of Bleeding and Adverse Events in CSPH Patients Undergoing Elective Procedures [ Time Frame: 36-48 months ]

Central Contacts

Related Studies