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

NCT06262750 | Recruiting

• 1 other identifier: 00375/23
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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

Conditions

Splanchnic Vein Thrombosis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients referred to the Fondazione Policlinico Universitario Agostino Gemelli IRCCS for SVT, either as inpatients or outpatients, and requiring anticoagulant therapy will be eligible for inclusion in this study

You may qualify if:

• 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);
• ongoing anticoagulant treatment with vitamin K-antagonists (VKA), direct oral anticoagulants (DOAC), low molecular weight heparin (LMWH), fondaparinux

You may not qualify if:

• splanchnic vein tumor thrombosis;
• absence of antithrombotic prophylaxis

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

UOC Servizio e DH Ematologia

Rome, 00168, Italy

RECRUITING

Central Study Contacts

valerio de stefano

CONTACT

+390630154206; valerio.destefano@unicatt.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: February 16, 2024
• Study Start: December 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: November 1, 2025
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

IT (1)