Cirrhotic and Non-cirrhotic Patients With Clinically Significant Portal Hypertension

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

Age < 18 years;

Life expectancy < 6 months;

Patients unable to sign informed consent.

Trial population

This study will include both cirrhotic and non-cirrhotic inpatients and outpatients with CSPH undergoing elective procedures.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

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.

Time frame
36-48 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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