Cirrhotic and Non-cirrhotic Patients With Clinically Significant Portal Hypertension

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.

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Key information

Conditions

Cirrhosis, Liver Clinically Significant Portal Hypertension(CSPH) Digestive System Diseases Fibrosis Gastroesophageal Varices Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Roma, 00168, Italy

Location contact

Francesco PI Santopaolo

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: 36-48 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabetta SC Creta

CONTACT

[email protected]

3480778584

Francesco PI Santopaolo

CONTACT

[email protected]

3492754288

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: PREDIBLEED

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2030
First posted: Feb 12, 2026
Registry last updated: Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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