Trials / Not Yet Recruiting

Not Yet RecruitingNCT07405749

Cirrhotic and Non-cirrhotic Patients With Clinically Significant Portal Hypertension

Incidence and Predictive Factors of Elective Procedure-Related Bleeding in Cirrhotic and Non-Cirrhotic Patients With Clinically Significant Portal Hypertension

Status: Not Yet Recruiting
Phase: —
Study type: Observational
Enrollment: 2,500 (estimated)

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

All cirrhotic and non-cirrhotic patients with clinically significant portal hypertension undergoing elective procedures will be followed to assess the occurrence of major bleeding events and other adverse outcomes. Outcomes will include bleeding events, classified according to ISTH criteria as major, clinically relevant non-major, and minor bleeding; venous and arterial thrombotic events, diagnosed using objective methods and classified as symptomatic or incidental in accordance with ISTH recommendations; and liver-related events, including variceal bleeding, ascites, bacterial infections, and hepatic encephalopathy, clinically assessed during follow-up.

Conditions

Timeline

Start date: 2026-02-01
Primary completion: 2029-02-01
Completion: 2030-02-01
First posted: 2026-02-12
Last updated: 2026-02-12

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT07405749. Inclusion in this directory is not an endorsement.