Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis: A Randomized Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- McMaster University
- Enrollment
- 1,727
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
1
Selective D-Dimer use
Intervention: D-dimer testing (Procedure)
2
Uniform D-Dimer use
Intervention: D-dimer testing (Procedure)
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)