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.
* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
1,727
Uniform D-dimer use
Selective D-Dimer use
Hamilton Health Sciences, McMaster
Hamilton, Ontario, Canada
St. Joseph's Health Care Centre
Hamilton, Ontario, Canada
Hamilton Health Sciences, Henderson
Hamilton, Ontario, Canada
Hamilton Health Sciences, General
Hamilton, Ontario, Canada
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
Time frame: 3 Months
bleeding
Time frame: 3 Months
healthcare utilization
Time frame: 3 Months
cost-effectiveness
Time frame: 3 Months
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SMBD Jewish General Hospital
Montreal, Quebec, Canada