Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182221
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2005-09-13
Brief Title:
Safety of a Diagnostic Strategy With D-Dimer Testing for PE
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer Testing in Patients With Suspected Pulmonary Embolism
Status:
COMPLETED
Status Verified Date:
2017-03
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:
None
Brief Summary:
To determine whether D-Dimer testing using the MDA D-Dimer assay can be used to simplify the diagnostic process for pulmonary embolism PE This will be assessed by performing a cohort study in 1000 patients with suspected PE
To ascertain if an MDA D-Dimer result of less than 075 ugmL FEU obviates the need for further testing and therapy in patients with suspected PE
To ascertain if an MDA D-Dimer result of less than 075 ugmL FEU obviates the need for further testing and therapy in patients with suspected PE
Detailed Description:
Prospective cohort study of 1000 patients in which those with a negative D-Dimer result undergo no further testing and are followed for 3 months for venous thromboembolism Patients with a positive D-Dimer undergo standardized testing
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Grant NA 5154 | None | None | None |