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

Brief Summary

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

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
  • Study Primary Completion Date: June 2010

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • Procedure: D-dimer testing
    • Uniform D-dimer use
  • Procedure: D-dimer testing
    • Selective D-Dimer use

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Selective D-Dimer use
  • Active Comparator: 2
    • Uniform D-Dimer use

Outcome Measures for this Clinical Trial

Primary Measures

  • 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
      Safety Issue?: Yes

Secondary Measures

  • bleeding
    • Time Frame: 3 Months
      Safety Issue?: Yes
  • healthcare utilization
    • Time Frame: 3 Months
      Safety Issue?: No
  • cost-effectiveness
    • Time Frame: 3 Months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • McMaster University
  • Collaborator
    • Heart and Stroke Foundation of Ontario
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lori Linkins, MD, Principal Investigator, McMaster University
    • Clive Kearon, MD, Principal Investigator, McMaster University
    • Jim Julian, MMath, Principal Investigator, McMaster University, Dept. of Clinical Epidemiology and Biostatistics

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00157677