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NCT07405749Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 12 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
2500 (estimated)
First submitted
5 Feb 2026
Start date
Feb 2026
Primary completion date
Feb 2029
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT07405749

What you commit to

  • Study type: Observational
  • Planned participants: 2500
  • From Feb 2026 to the primary completion date, Feb 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Age \< 18 years;

Other

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

Who the study is looking for

  • 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);

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli,
Coordinator of this site? Confirm its status
RomaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.