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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.
All cirrhotic and non-cirrhotic patients with clinically significant portal hypertension undergoing elective procedures will be followed to assess the occurrence of major bleeding events and other adverse outcomes. Outcomes will include bleeding events, classified according to ISTH criteria as major, clinically relevant non-major, and minor bleeding; venous and arterial thrombotic events, diagnosed using objective methods and classified as symptomatic or incidental in accordance with ISTH recommendations; and liver-related events, including variceal bleeding, ascites, bacterial infections, and hepatic encephalopathy, clinically assessed during follow-up.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36-48 months |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include both cirrhotic and non-cirrhotic inpatients and outpatients with CSPH undergoing elective procedures.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco PI Santopaolo | Contact | 3492754288 | francesco.santopaolo@policlinicogemelli.it | |
| Elisabetta SC Creta | Contact | 3480778584 | elisabetta.creta@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Santopaolo | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli, | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |