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

Splanchnic Vein Thrombosis Clinical Trial

— SAPIENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262750
• Other study ID #: 00375/23
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: February 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: valerio de stefano
• Phone: +390630154206
• Email: valerio.destefano[@]unicatt.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: November 1, 2025
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Splanchnic Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Italy	UOC Servizio e DH Ematologia	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 1 year
Primary	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	through study completion, an average of 1 year
Primary	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).	every six months, up to 2 years
Primary	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	through study completion, an average of 1 year