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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   Information provided by McMaster University
First Received: September 8, 2005   Last Updated: September 17, 2009   History of Changes

September 8, 2005
September 17, 2009
October 2004
July 2010   (final data collection date for 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 ]
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
Complete list of historical versions of study NCT00157677 on ClinicalTrials.gov Archive Site
  • 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 ]
  • bleeding
  • healthcare utilization
  • cost-effectiveness
 
Selective D-Dimer Testing Compared With Uniform D-Dimer Testing in the Diagnosis of Deep Vein Thrombosis (SELECT)
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.

  • 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.

Phase III
Interventional
Diagnostic, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Deep Vein Thrombosis
Procedure: D-dimer testing
  • Experimental: Selective D-Dimer use
  • Active Comparator: Uniform D-Dimer use
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
2000
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Clare Stewart, MA 905-527-2299 ext 43791 stewartc@mcmaster.ca
Contact: Rosemarie Miksza-Todd 905-527-2299 ext 43798 mikszat@mcmaster.ca
Canada
 
NCT00157677
Lori Linkins, MD, McMaster University
CTMG-2005-SELECT, Grant Number: NA 5429
McMaster University
Heart and Stroke Foundation of Ontario
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
McMaster University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP