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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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