Evaluating anticoagulation treatment for splanchnic vein thrombosis
Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study
This study is testing whether blood-thinning treatment is safe and effective for people with splanchnic vein thrombosis over a two-year period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06262750 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and efficacy of anticoagulation therapy in patients diagnosed with splanchnic vein thrombosis (SVT). Patients will be monitored for a minimum of 24 months to track the incidence of recurrent thrombosis and bleeding events during their treatment. The study will include both hospitalized and outpatient individuals, providing a comprehensive view of treatment outcomes. The research will begin upon patient referral to the center for SVT and will conclude at the 24-month follow-up or upon the occurrence of specific outcome events.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of deep vein thrombosis involving splanchnic veins, regardless of liver cirrhosis status.
Not a fit: Patients with splanchnic vein tumor thrombosis or those without antithrombotic prophylaxis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment protocols for patients with splanchnic vein thrombosis, potentially reducing the risk of recurrent thrombosis and bleeding.
How similar studies have performed: While there may be existing studies on anticoagulation in other contexts, this specific focus on splanchnic vein thrombosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rome
- UOC Servizio e DH Ematologia — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: valerio de stefano
- Email: valerio.destefano@unicatt.it
- Phone: +390630154206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.