Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-01 @ 2:56 PM
Study NCT ID:
NCT03477968
Status:
TERMINATED
Last Update Posted:
2025-02-25
First Post:
2018-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ThRombosis ExclUsion STudy
Sponsor:
Diagnostica Stago
Organization:
Study Overview
Official Title:
ThRombosis ExclUsion STudy
Status:
TERMINATED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the unstability of samples included in the plasmabank using the reference method: VIDAS system, Stago decided to not use the plasmabank to assess the pre-specified primary objective. Therefore, this study was halted prematurely.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRUST
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: