Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study

Recruiting

• Conditions: Splanchnic Vein Thrombosis

• Registration Number: NCT06262750
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

Prospective single-centre, observational study with medical products. Patients with a medical history of SVT will be observed for at least 24 months after inclusion. The study will begin when the patient is referred to our centre for SVT and will end at the 24-month follow-up or at the occurrence of a study outcome event, or in case of Death OBJECTIVE: To prospectively define the incidence of recurrent thrombosis and bleeding events during anticoagulant therapy in patients with diagnosed SVT, regardless of whether they will be hospitalized or treated as outpatients

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-07
• Study Start: 2023-12-01
• Primary Completion: 2023-12-01
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-16
• Last Update Posted: 2024-02-16
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of venous and arterial thromboembolic events	through study completion, an average of 1 year	All venous and arterial thromboembolic (VTE and ATE) events during the study period will be registered and counted
Rate of progress /stable /regressive	every six months, up to 2 years	To evaluate the impact of anticoagulation therapy on SVT, all enrolled patients will undergo imaging test (doppler ultrasound, contrast-enhanced CT or MR angiography).
Incidenze of bleedings events	through study completion, an average of 1 year	Bleeding events will be classified according to ISTH definition, as follows:major bleedings,clinically relevant non-major bleedings (CRNMB), minor bleedings
incidence of liver related events	through study completion, an average of 1 year	To evaluate the onset of liver-related events (variceal bleeding, ascites, bacterial infections, and hepatic encephalopathy), all enrolled patients will be clinically assessed

Trial Locations

Locations (1)

UOC Servizio e DH Ematologia; 🇮🇹 Rome, Italy