Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis (SELECT)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis: A Randomized Trial

Conditions
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Deep Vein Thrombosis

Intervention / Treatment
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* Procedure: D-dimer testing
* Procedure: D-dimer testing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Selective D-Dimer use | Procedure: D-dimer testing<br>* Selective D-Dimer use<br>|
| Active Comparator: 2<br>Uniform D-Dimer use | Procedure: D-dimer testing<br>* Uniform D-dimer use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding |  | 3 Months | 
| healthcare utilization |  | 3 Months | 
| cost-effectiveness |  | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep vein thrombosis, pulmonary embolism, D-dimer testing