Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480994
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-17
Brief Title:
Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support
Sponsor:
Diagnostica Stago RD
Organization:
Diagnostica Stago RD
Study Overview
Official Title:
Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support With Fresh Plasma on Any Patient With VTE Suspicion
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXTEND
Brief Summary:
The goal of this non interventional study is to demonstrate the diagnostic performances on fresh plasmas in comparison with the performances on frozen plasmas in any patients with VTE suspicion whatever the pre-test probability The main question it aims to answer is
Are the performances equivalent on fresh plasmas in comparison with frozen plasmas or is it necessary to determine a new algorithm of the Clinical Decision Support with a new cut-off Participants will be diagnosed and treated in accordance with routine standard of care
Are the performances equivalent on fresh plasmas in comparison with frozen plasmas or is it necessary to determine a new algorithm of the Clinical Decision Support with a new cut-off Participants will be diagnosed and treated in accordance with routine standard of care
Detailed Description:
Establish the diagnostic performance of the Clinical Decision Support tool on fresh plasma in PE and in DVT in comparison with that on frozen plasma and in comparison with the current diagnostic strategy on the entire population and on the following different subpopulations
Patients eligible for D-dimer assay with low or moderate clinical probability compared to the reference diagnosis imaging and D-Dimer adjusted and not adjusted for age
Patients with high clinical probability compared to the reference diagnosis imaging
Patients not eligible for D-dimer assay either with a condition associated with increased D-dimer levels in the absence of VTE or with a history of PE or DVT for less than 3 months or suspected thrombotic events
Patients with known and active cancer
Patients with COVID-19 The assays will be conducted on a fresh and frozen plasma aliquots
Patients eligible for D-dimer assay with low or moderate clinical probability compared to the reference diagnosis imaging and D-Dimer adjusted and not adjusted for age
Patients with high clinical probability compared to the reference diagnosis imaging
Patients not eligible for D-dimer assay either with a condition associated with increased D-dimer levels in the absence of VTE or with a history of PE or DVT for less than 3 months or suspected thrombotic events
Patients with known and active cancer
Patients with COVID-19 The assays will be conducted on a fresh and frozen plasma aliquots
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None