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.

Condition	Intervention	Phase
Deep Vein Thrombosis	Procedure: D-dimer testing	Phase III

Further Study Details: 

Primary Outcomes: 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
Secondary Outcomes: bleeding; healthcare utilization; cost-effectiveness
Expected Total Enrollment:  2000

• 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00157677

Donna McCarty      905-527-2299  Ext. 42607    mccartyd@mcmaster.ca
Kathryn Cline      905-527-2299  Ext. 42638    clinek@mcmaster.ca

Canada, Ontario
      Hamilton Health Sciences, Henderson, Hamilton,  Ontario,  L8V 1C3,  Canada; Recruiting
      Hamilton Health Sciences, McMaster, Hamilton,  Ontario,  L8N 3Z5,  Canada; Recruiting
      Hamilton Health Sciences, General, Hamilton,  Ontario,  Canada; Not yet recruiting
      St. Joseph''''s Health Care Centre, Hamilton,  Ontario,  L8N 4A6,  Canada; Recruiting
Canada, Quebec
      SMBD Jewish General Hospital, Montreal,  Quebec,  H3T 1E2,  Canada; Recruiting

Study chairs or principal investigators

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   

Study ID Numbers:  CTMG-2005-SELECT; Grant Number: NA 5429
Last Updated:  September 10, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00157677
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13