Safety of a Diagnostic Strategy With D-Dimer Testing for PE
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 0.75 ug/mL FEU obviates the need for further testing and therapy in patients with suspected PE.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer Testing in Patients With Suspected Pulmonary Embolism|
- Venousthromboembolism [ Time Frame: 3 months ]
|Study Start Date:||August 2003|
|Study Completion Date:||April 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182221
|Hamilton Health Sciences-McMaster Campus|
|Hamilton, Ontario, Canada, L8V 1C3|
|Hamilton Health Sciences-Henderson Campus|
|Hamilton, Ontario, Canada, L8V !C3|
|St Joseph's Health Care Centre|
|Hamilton, Ontario, Canada, L8N 4A6|
|Hamilton Health Sciences, General|
|Hamilton, Ontario, Canada|
|Principal Investigator:||Shannon M Bates, MDCM,MSc||Hamilton Health Sciences Corporation|