Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis: A Randomized Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Deep Vein Thrombosis
- Sponsor
- McMaster University
- Enrollment
- 1727
- Locations
- 5
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- bleeding(3 Months)
- healthcare utilization(3 Months)
- cost-effectiveness(3 Months)