Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT03477968
Brief 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.
Study:
NCT03477968
Study Brief:
Protocol Section:
NCT03477968