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

Status: Recruiting
Location: See location...
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
UOC Servizio e DH Ematologia
RECRUITING
Rome
Contact Information
Primary
valerio de stefano
valerio.destefano@unicatt.it
+390630154206
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 170
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov