Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis (SELECT)
- Conditions
- Deep Vein Thrombosis
- Interventions
- Procedure: D-dimer testing
- Registration Number
- NCT00157677
- Lead Sponsor
- McMaster University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1727
- Age 18 and older
- Presenting with symptoms compatible with clinically suspected deep vein thrombosis
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 D-dimer testing Uniform D-Dimer use 1 D-dimer testing Selective D-Dimer use
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method bleeding 3 Months healthcare utilization 3 Months cost-effectiveness 3 Months
Trial Locations
- Locations (5)
Hamilton Health Sciences, McMaster
🇨🇦Hamilton, Ontario, Canada
St. Joseph's Health Care Centre
🇨🇦Hamilton, Ontario, Canada
SMBD Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Hamilton Health Sciences, General
🇨🇦Hamilton, Ontario, Canada
Hamilton Health Sciences, Henderson
🇨🇦Hamilton, Ontario, Canada