Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-31 @ 5:12 PM
Study NCT ID:
NCT01221805
Status:
COMPLETED
Last Update Posted:
2016-08-05
First Post:
2010-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism
Sponsor:
Diagnostica Stago
Organization:
Study Overview
Official Title:
STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism
Status:
COMPLETED
Status Verified Date:
2016-08
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:
DiET
Brief Summary:
The purpose of this study is to demonstrate the ability of STA® Liatest® D-Di combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism (PE) or Deep Venous Thrombosis (DVT) in a 3 month follow-up.
Detailed Description:
The study population will be selected from prospective, consecutive ambulatory outpatients suspected of having venous thromboembolism.
These patients will first be evaluated using the Wells score:
* patients with low or moderate pretest probability will be considered for D-dimer testing, those with D-dimer positive will be considered for an imaging procedure,
* patients with high pretest probability will be considered for an imaging procedure.
Patients with "low or moderate" pretest probability and a negative D-Dimer result will be followed for 3 months to evaluate potential development of deep venous thrombosis and/or pulmonary embolism.
These patients will be contacted by phone 3 month after their first visit.
These patients will first be evaluated using the Wells score:
* patients with low or moderate pretest probability will be considered for D-dimer testing, those with D-dimer positive will be considered for an imaging procedure,
* patients with high pretest probability will be considered for an imaging procedure.
Patients with "low or moderate" pretest probability and a negative D-Dimer result will be followed for 3 months to evaluate potential development of deep venous thrombosis and/or pulmonary embolism.
These patients will be contacted by phone 3 month after their first visit.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: