Status:
COMPLETED
Safety of a Diagnostic Strategy With D-Dimer Testing for PE
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Heart and Stroke Foundation of Ontario
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To determine whether D-Dimer testing, using the MDA D-Dimer assay, can be used to simplify the diagnostic process for pulmonary embolism (PE). This will be assessed by performing a cohort study in 100...
Detailed Description
Prospective cohort study of 1000 patients in which those with a negative D-Dimer result undergo no further testing and are followed for 3 months for venous thromboembolism. Patients with a positive D-...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Suspected PE
Exclusion
- Treatment with full-dose anticoagulants for 24 hours or more OR an ongoing requirement for anticoagulants
- Other tests for PE performed prior to eligibility assessment (e.g.other D-Dimer, V/Q scan, pulmonary angiogram, spiral CT, compression ultrasound, venogram).
- Cardiorespiratory instability requiring immediate performance of other tests to diagnose or exclude PE (i.e. inability to wait 30-60 minutes for MDA D-Dimer result)
- Comorbid condition limiting survival to less than three months
- Patient has been asymptomatic for seven days prior to presentation
- Current pregnancy
- Contraindication to contrast (e.g., allergy, renal failure).
- Geographic in accessibility which precludes follow-up
- Presence of central venous catheter (permanent or temporary, including PICC line) at the time of eligibility assessment
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00182221
Start Date
August 1 2003
End Date
April 1 2008
Last Update
March 30 2017
Active Locations (4)
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1
St Joseph's Health Care Centre
Hamilton, Ontario, Canada, L8N 4A6
2
Hamilton Health Sciences-Henderson Campus
Hamilton, Ontario, Canada, L8V !C3
3
Hamilton Health Sciences-McMaster Campus
Hamilton, Ontario, Canada, L8V 1C3
4
Hamilton Health Sciences, General
Hamilton, Ontario, Canada