NCT03477968

ThRombosis ExclUsion STudy

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 5,935 (actual)
• Sponsor: Diagnostica Stago · Industry
• Sex: All
• Age: 79 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: To demonstrate the ability of STA® - Liatest® D-Di XL combined with a clinical PreTest Probability (PTP) to safely exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) as measured by Negative Predictive Value (NPV) and sensitivity. Secondary objectives: 1. To estimate additional STA® - Liatest® D-Di XL accuracy parameters, including specificity and positive predictive value (PPV) 2. To constitute a plasma bank to be used for future studies with other DDi assays under development by Stago.

Detailed description

The study population will be selected from prospective, consecutive ambulatory outpatients suspected of having venous thromboembolism. Patients will be diagnosed for VTE (PE or DVT) based on local standard of care. Samples will be collected (additional blood draw or additional volume during blood draw) for future testing with new D-Dimer assay. In case of Low/Moderate PTP score and negative VTE diagnosis, patients will be followed for 3 months to evaluate potential development of deep venous thrombosis and/or pulmonary embolism.

Conditions

• Deep Venous Thromboses
• Pulmonary Embolism
• Venous Thromboembolism

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	DDimer test	Measuring the level of DDimer in blood sample

Timeline

• Start date: 2018-06-25
• Primary completion: 2023-03-29
• Completion: 2024-09-05
• First posted: 2018-03-27
• Last updated: 2025-02-25
• Results posted: 2025-01-27

Locations

20 sites across 5 countries: United States, Belgium, France, Italy, Spain

Regulatory

• FDA-regulated device study