An observational study in Pulmonary Embolism, sponsored by McMaster University. Completed at 9 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by McMaster University · Observational
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.
738 studies on the registry are indexed under Pulmonary Embolism; 158 are open to participants now.
This study's enrollment of 2,038 is above the median of 383 across 323 observational studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male or female patients (either outpatients or inpatients) with clinically suspected Pulmonary Embolism.
Exclusion Criteria:
Computed Tomography Pulmonary Angiogram or Ventilation Perfusion Scan was performed:
Low Clinical Pretest Probability with D-dimer \< 1000 ug/L and Moderate Clinical Pretest Probability with D-dimer \< 500ug/L
Low Clinical Pretest Probability with D-dimer \> or = 1000ug/L and Moderate Clinical Pretest Probability with D-dimer \> or = 500 ug/L and High Clinical Pretest Probability
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)
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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