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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Splanchnic Vein Thrombosis

Study type: Observational

Funder types: Other

Identifiers

NCT06262750

00375/23

Details and patient eligibility

About

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

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• age ≥ 18 years
• ability to provide informed consent;
• confirmed diagnosis of deep vein thrombosis involving splanchnic veins in liver cirrhosis (with or without hepatocarcinoma);
• confirmed diagnosis of deep vein thrombosis involving splanchnic veins in absence of liver cirrhosis (with or without portal cavernoma);
• pregnant patients will be eligible for inclusion in the study;
• ongoing anticoagulant treatment with vitamin K-antagonists (VKA), direct oral anticoagulants (DOAC), low molecular weight heparin (LMWH), fondaparinux

EXCLUSION CRITERIA

• splanchnic vein tumor thrombosis;
• absence of antithrombotic prophylaxis