Member zone

Extended Secondary Prevention of splAnchniC vEin thrombosis: an observational study (SPACE.Val study)

May 12, 2026

Background

Splanchnic vein thrombosis (SVT) is an uncommon location of venous thromboembolism (VTE), with potential serious short- and long-term health risks. 
Anticoagulation is the standard treatment, usually with heparin followed by vitamin K antagonists (VKAs). Direct oral anticoagulants (DOACs) are easier to use because they are oral, fixed-dose, and require no routine monitoring.
This study aims to evaluate current long-term SVT treatment strategies, DOAC safety/effectiveness, and patient quality of life.

Design

Multicenter, exploratory observational prospective cohort study.

Expected total duration of the study: 5 years

 

Study population

Inclusion criteria:

  • Consecutive adult patients (≥ 18 years)
  • Obtainment of written informed consent
  • Thrombosis of the splanchnic veins (including portal, mesenteric, splenic veins, and Budd-Chiari), objectively diagnosed by computerized tomography, magnetic resonance imaging, or Doppler ultrasonography
  • Treated for at least 3 months with any anticoagulant treatment at standard therapeutic doses
  • Indication to continue anticoagulant treatment for secondary prevention of recurrent SVT or other site VTE at the discretion of the treating physician
  • Signed informed consent where required

Exclusion criteria:

  • Indication for concomitant dual antiplatelet treatment
  • Life expectancy less than 6 months

Data curation

RedCap eCRF https://redcap.isth.org/
Back to projects

Project recruiting

Aims

The primary study endpoint will be a composite of objectively documented adjudicated:

  • ISTH defined major bleeding
  • Fatal and non-fatal, symptomatic or incidentally detected, recurrent SVT (defined as SVT progression or SVT in a previously patent vessel) and VTE at other locations (such as pulmonary embolism, deep vein thrombosis in the upper/lower extremities or other deep veins)
  • Fatal and non-fatal arterial thrombotic events (STEMI, NSTEMI, ischemic stroke, TIA, acute peripheral artery thrombosis)

 

Secondary endpoints will include:

  • Individual components of the primary outcome
  • Response to treatment in the portal vein according to the VALDIG criteria (complete resolution, improvement, stability, progression)
  • Modified ISTH definition of major bleeding which includes bleeding requiring hospitalization
  • ISTH defined clinically relevant non-major bleeding events
  • All-cause mortality
  • Quality of life of SVT using available psychometric questionnaires
  • Self-reported patient adherence to anticoagulant treatment
  • Switch from DOACs to VKAs or to another DOAC and switch from VKAs to DOACs
  • Interruption of anticoagulant treatment

Study file(s)

Project : Space study proposal for VALDIG

CRF : 0-baseline_05.12.2025 1-6months_05.12.2025 2-12months_05.12.2025 3-18months_05.12.2025 4-24months_05.12.2025

Link to the redCap CRF https://redcap.isth.org/

Contact(s)

Pr Walter Ageno
walter.ageno@unipd.it
Marco Senzolo
marcosenzolo@hotmail.com

Not seeing file(s) and contact(s) details for this project?

Become member