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Clinical Trial Summary

The purpose of this study is to demonstrate the ability of new D-Dimer assay combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism (PE) or Deep Venous Thrombosis (DVT) in a 3 month follow-up.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03477968
Study type Observational
Source Diagnostica Stago
Contact
Status Active, not recruiting
Phase
Start date June 25, 2018
Completion date December 31, 2024

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