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

February 15, 2024 updated by: DE STEFANO VALERIO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 Overview

Status

Recruiting

Conditions

Splanchnic Vein Thrombosis

Study Type

Observational

Enrollment (Estimated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: valerio de stefano
Phone Number: +390630154206
Email: valerio.destefano@unicatt.it

Study Locations

Italy
- - Rome, Italy, 00168
    - Recruiting
    - UOC Servizio e DH Ematologia
    - Sub-Investigator:
      
      Silvia Betti
    - Contact:
      
      Valerio De Stefano
    - Sub-Investigator:
      
      Rossella Talerico
    - Sub-Investigator:
      
      Francesco Santopaolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidenze of bleedings events Time Frame: through study completion, an average of 1 year	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 Time Frame: through study completion, an average of 1 year	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 Time Frame: every six months, up to 2 years	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 Time Frame: through study completion, an average of 1 year	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)