Bleeding after planned procedures in people with cirrhosis or portal hypertension
Looks at bleeding after planned procedures in adults with portal hypertension.
Plain-language title generated from the registry record
Registry title: Cirrhotic and Non-cirrhotic Patients With Clinically Significant Portal Hypertension
Key facts
- Where
- Roma, ItalySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with clinically significant portal hypertension, with or without cirrhosis, who show specific signs of it.
- Age
- Older than 18 years.
- Sex
- All sexes can join.
- Disease stage
- Clinically significant portal hypertension, shown by gastroesophageal varices, porto-systemic collaterals, liver stiffness above 25 KPa or spleen stiffness above 50 KPa.
Main reasons for not taking part
- Younger than 18 years
- Life expectancy under 6 months
- Unable to give informed consent
Read by machine on 13 November 2026.
Where in Italy
- Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli,Roma, ItalyContact: Francesco PI Santopaolo (principal investigator)No longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT07405749
- Record updated
- 12 February 2026
- Original description
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.Read full original descriptionShow less
Incidence and Predictive Factors of Elective Procedure-Related Bleeding in 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.
Inclusion: 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: Age < 18 years; Life expectancy < 6 months; Patients unable to sign informed consent.