Status:

COMPLETED

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

Lead Sponsor:

McMaster University

Collaborating Sponsors:

Heart and Stroke Foundation of Ontario

Conditions:

Deep Vein Thrombosis

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 ...

Eligibility Criteria

Inclusion

  • Age 18 and older
  • Presenting with symptoms compatible with clinically suspected deep vein thrombosis

Exclusion

  • 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.

Key Trial Info

Start Date :

October 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2010

Estimated Enrollment :

1727 Patients enrolled

Trial Details

Trial ID

NCT00157677

Start Date

October 1 2004

End Date

June 1 2010

Last Update

October 27 2011

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Hamilton Health Sciences, McMaster

Hamilton, Ontario, Canada, L8N 3Z5

2

St. Joseph's Health Care Centre

Hamilton, Ontario, Canada, L8N 4A6

3

Hamilton Health Sciences, Henderson

Hamilton, Ontario, Canada, L8V 1C3

4

Hamilton Health Sciences, General

Hamilton, Ontario, Canada