Clinical Trial

Cirrhotic and Non-cirrhotic Patients With Clinically Significant Portal Hypertension

Study acronym: PREDIBLEED
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07405749
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Cirrhosis, Liver, Portal Hypertension, Clinically Significant Portal Hypertension(CSPH), Gastroesophageal Varices
Enrollment 2,500 participants
Start Date 2026-02
Primary Completion 2029-02 (estimated)
Study Completion 2030-02 (estimated)
Updated on ClinicalTrials.gov 2026-02-12