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Cirrhotic and Non-cirrhotic Patients With Clinically Significant Portal Hypertension

NCT07405749 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2026-02-12

No results posted yet for this study

Summary

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.

Conditions

  • Cirrhosis, Liver
  • Portal Hypertension
  • Clinically Significant Portal Hypertension(CSPH)
  • Gastroesophageal Varices

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Francesco Santopaolo · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2029-02-28
Completion
2030-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07405749 on ClinicalTrials.gov