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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07405749
Acronym
PREDIBLEED
Enrollment
2500
Registered
2026-02-12
Start date
2026-02-01
Completion date
2030-02-01
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Thrombotic events, porto-systemic collaterals

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.

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.

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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);

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Bleeding and Adverse Events in CSPH Patients Undergoing Elective Procedures36-48 monthsTo 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.

Countries

Italy

Contacts

CONTACTFrancesco PI Santopaolo
francesco.santopaolo@policlinicogemelli.it3492754288
CONTACTElisabetta SC Creta
elisabetta.creta@policlinicogemelli.it3480778584
PRINCIPAL_INVESTIGATORFrancesco Santopaolo

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026