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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS170 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

170

Conditions

Splanchnic Vein Thrombosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

Incidenze of bleedings events

Bleeding events will be classified according to ISTH definition, as follows:major bleedings,clinically relevant non-major bleedings (CRNMB), minor bleedings

Time frame: through study completion, an average of 1 year

Incidence of venous and arterial thromboembolic events

All venous and arterial thromboembolic (VTE and ATE) events during the study period will be registered and counted

Time frame: through study completion, an average of 1 year

Rate of progress /stable /regressive

To evaluate the impact of anticoagulation therapy on SVT, all enrolled patients will undergo imaging test (doppler ultrasound, contrast-enhanced CT or MR angiography).

Time frame: every six months, up to 2 years

incidence of liver related events

To evaluate the onset of liver-related events (variceal bleeding, ascites, bacterial infections, and hepatic encephalopathy), all enrolled patients will be clinically assessed

Time frame: through study completion, an average of 1 year

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts