Deep Vein Thrombosis
Conditions
Keywords
deep vein thrombosis, pulmonary embolism, D-dimer testing
Brief summary
The purpose of this study is to compare two diagnostic interventions to improve the way D-dimer blood testing (MDA D-dimer) is used to diagnose first time symptomatic deep vein thrombosis.
Detailed description
* Limiting use of D-dimer testing to outpatients with a Low or Moderate clinical pretest probability (C-PTP)for deep vein thrombosis AND using a D-dimer level of \< 1.0 µg FEU/mL to exclude deep vein thrombosis in those with a Low C-PTP, and a D-dimer level of \< 0.5 µg FEU/mL to exclude deep vein thrombosis in those with a Moderate C-PTP, is as safe and a more efficient way to diagnose DVT than: * Performing D-dimer testing in all patients with suspected deep vein thrombosis with use of a single D-dimer value of \< 0.5 µg FEU/mL to exclude thrombosis (current practice). All randomized patients, including those who are treated for deep vein thrombosis after initial testing, will be followed for a period of 3 months to monitor for signs and symptoms suggestive of deep vein thrombosis, pulmonary embolism, bleeds and death.
Interventions
PROCEDURED-dimer testing
Uniform D-dimer use
Sponsors
Heart and Stroke Foundation of Ontario
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 and older * Presenting with symptoms compatible with clinically suspected deep vein thrombosis
Exclusion criteria
* Treatment with full dose anticoagulation for 24 hours or more. * Other test for deep vein thrombosis already performed. * Ongoing need for therapeutic anticoagulant therapy. * Life expectancy less than 3 months. * Absence of acute symptoms within 7 days of presentation. * Presenting with symptoms of pulmonary embolism. * Previous confirmed episode of deep vein thrombosis or pulmonary embolism. * Current pregnancy. * Geographic inaccessibility which precludes follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objectively confirmed proximal deep vein thrombosis or pulmonary embolism during 3 months of follow-up in patients who are not diagnosed with deep vein thrombosis during diagnostic testing and are not anticoagulated | 3 Months |
Secondary
| Measure | Time frame |
|---|---|
| bleeding | 3 Months |
| healthcare utilization | 3 Months |
| cost-effectiveness | 3 Months |
Countries
Canada
Outcome results
None listed