Cirrhotic and Non-cirrhotic Patients With Clinically Significant Portal Hypertension

NCT07405749 | Not Yet Recruiting

• 1 other identifier: 13663
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Thrombotic events; porto-systemic collaterals

Outcome Measures

Primary Outcomes (1)

• Incidence of Bleeding and Adverse Events in CSPH Patients Undergoing Elective Procedures

  To prospectively define the incidence of bleeding and other adverse events in patients with clinically significant portal hypertension (CSPH) who undergo elective low and high risk procedures.

  36-48 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will include both cirrhotic and non-cirrhotic inpatients and outpatients with CSPH undergoing elective procedures.

You may qualify if:

• Age \> 18 years;
• Ability to provide informed consent;
• Specific signs of CSPH (gastroesophageal varices, porto-systemic collaterals, liver stiffness measurement (LSM) \> 25 KPa or spleen stiffness measurement (SSM) \> 50 KPa);

You may not qualify if:

• Age \< 18 years;
• Life expectancy \< 6 months;
• Patients unable to sign informed consent.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli,

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesco Santopaolo

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco PI Santopaolo

CONTACT

3492754288; francesco.santopaolo@policlinicogemelli.it

Elisabetta SC Creta

CONTACT

3480778584; elisabetta.creta@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

IT (1)