Cirrhotic and Non-cirrhotic Patients With Clinically Significant Portal Hypertension

Starting soon

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

In brief

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.

Key facts

Study ID

NCT07405749

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

2500

Starts

2026-02-01

Expected to finish

2030-02-01

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli, — Roma, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.