PREDIBLEED
Incidence and Predictive Factors of Elective Procedure-Related Bleeding in Cirrhotic and Non-Cirrhotic Patients With Clinically Significant Portal Hypertension
Sponsor study identifier
observational
2,500
1 country
1
Study Start
February 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 5, 2026
Actual (reported)February 12, 2026
Actual (reported)February 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
This study will include both cirrhotic and non-cirrhotic inpatients and outpatients with CSPH undergoing elective procedures.
Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli,
Roma, 00168, Italy
Francesco Santopaolo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First Submitted
February 5, 2026
First Posted
February 12, 2026
Study Start
February 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 2029
EstimatedTwo-dimensional Shear Wave Elastography for Assessment of Cirrhosis and Portal Hypertension
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 12, 2026
Record last verified: 2026-02
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