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

This study is currently recruiting participants.
Study NCT00157677.   Last updated on December 2, 2008.   Information provided by McMaster University

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Descriptive Information Fields
Brief Title  Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis (SELECT)
Official Title  Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis: A Randomized Trial
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 Phase Phase III
Study Type  Interventional
Study Design  Diagnostic, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  bleeding [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
healthcare utilization [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
cost-effectiveness [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Condition  Deep Vein Thrombosis
Intervention  Procedure: D-dimer testing
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  2000
Start Date  October 2004
Completion Date June 2009
Eligibility Criteria 

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 Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Clare Stewart, MA     905-527-2299 ext 43791     stewartc@mcmaster.ca    
Contact: Rosemarie Miksza-Todd     905-527-2299 ext 43798     mikszat@mcmaster.ca    
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00157677
Organization ID CTMG-2005-SELECT
Secondary IDs †† Grant Number: NA 5429
Study Sponsor  McMaster University
Collaborators †† Heart and Stroke Foundation of Ontario
Investigators 
Principal Investigator:     Lori Linkins, MD     McMaster University    
Principal Investigator:     Clive Kearon, MD     McMaster University    
Principal Investigator:     Jim Julian, MMath     McMaster University, Dept. of Clinical Epidemiology and Biostatistics    
Information Provided By McMaster University
Verification Date December 2008
First Received Date  September 8, 2005
Last Updated Date December 2, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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