Prospective, multicentre, cohort study assessing a diagnostic management strategy for suspected Pulmonary Embolism with independent central adjudication of outcomes
This is a prospective, multi-centre, cohort study that will assess a new diagnostic management strategy for suspected Pulmonary Embolism (inpatients and outpatients). The new diagnostic strategy is designed to reduce the use of imaging tests for Pulmonary Embolism, particularly Computed Tomography Pulmonary Angiogram, by excluding Pulmonary Embolism with combinations of Clinical Pretest Probability and D-dimer results in a higher proportion of patients. The safety of this management strategy will be established by demonstrating a very low rate of proximal Deep Vein Thrombosis or Pulmonary Embolism during 90 days of follow-up in patients who had anticoagulant therapy withheld in response to negative diagnostic testing. Diagnostic test utilization will be assessed. All clinical outcomes will be adjudicated by a central independent adjudication committee that will be blind to initial D-dimer measurements and patient management.
Study Type
OBSERVATIONAL
Enrollment
2,038
University of Alberta Hospital
Edmonton, Alberta, Canada
HHS- Hamilton General Hospital
Hamilton, Ontario, Canada
St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
HHS - McMaster University Medical Centre
Hamilton, Ontario, Canada
Number of patients with confirmed symptomatic proximal Deep Vein Thrombosis or Pulmonary Embolism
Proximal Deep Vein Thrombosis includes thrombosis confined to the calf vein trifurcation but not isolated more distal Deep Vein Thrombosis. Pulmonary Embolism does not include isolated sub-segmental abnormalities on Computed Tomography Pulmonary Angiography.
Time frame: 90 Days (+ or - 7days)
Number of patients with bleeding
Major and minor bleeding
Time frame: 90 days (+ or - 7days)
Number of patient Deaths
All deaths and cause specific deaths
Time frame: 90 days (+ or - 7days)
Number of patients with Venous Thromboembolism
Venous Thromboembolism, including events that do not satisfy the primary outcome (e.g. isolated distal Deep Vein Thrombosis or subsegmental Pulmonary Embolism) but that are confirmed by the adjudication committee.
Time frame: 90 days (+ or - 7days)
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Juravinski Hospital
Hamilton, Ontario, Canada
London Health Sciences
London, Ontario, Canada
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Sherbrooke University Hospital
Sherbrooke, Quebec, Canada
Jewish General Hospital
Montreal, Canada