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.
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 Type
OBSERVATIONAL
Enrollment
5,935
Measuring the level of DDimer in blood sample
Yale New Haven Hospital
New Haven, Connecticut, United States
Northwestern Medical Center
Chicago, Illinois, United States
VTE Exclusion
According to the ThRombosis ExclUsion STudy (TRUST) protocol, the primary objective of the study was to demonstrate the ability of STA® - Liatest® D-Di XL combined with a clinical PreTest Probability to safely exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) as measured by Negative Predictive Value (NPV) and sensitivity. The first step was to evaluate the stability of the plasmabank using VIDAS system. The preliminary results showed that the plasmabank was unusable with a high rate of unstable samples. Stago, decided to not use this plasmabank to assess the ability of STA® - Liatest® D-Di XL to safely exclude PE and DVT.
Time frame: Initially, we planned to enroll subjects suspected of PE/DVT to constitute a plasmabank, then perform testing of STA- Liatest D-Di XL for on this latter on 48 months. However due to plasmabank unstability, Stago decided to not perform the testing phase.
VTE Exclusion
According to the ThRombosis ExclUsion STudy (TRUST) protocol, the secondary objectives of the study were: 1. To estimate additional STA® - Liatest® D-Di XL accuracy parameters, including specificity and positive predictive value (PPV) 2. To constitute a plasmabank to be used for future studies with other DDi assays under development by Stago. The first step was to evaluate the stability of the plasmabank using VIDAS system. The preliminary results showed that the plasmabank was unusable with a high rate of unstable samples. Stago, decided to not use this plasmabank to assess the ability of STA® - Liatest® D-Di XL to safely exclude PE and DVT and to not use this plasmabank for future studies with other DDi assays under development by Stago.
Time frame: Initially, we planned to enroll subjects suspected of PE/DVT to constitute a plasmabank, then perform testing of STA- Liatest D-Di XL. Due to plasmabank unstability, Stago decided to not perform the testing phase for the STA-D-Di XL and future DDi assays.
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