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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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This is a cohort study that will assess a new diagnostic management strategy for suspected Deep Vein Thrombosis in outpatients.The new diagnostic strategy is designed to reduce the use of ultrasound testing on the day of presentation, and reduce repeat ultrasound testing a week after an initial normal test.
This is a prospective, multicentre, cohort study that will assess a new diagnostic management strategy for suspected Deep Vein Thrombosis in outpatients. The new diagnostic strategy is designed to reduce the use of ultrasound testing on the day of presentation, and reduce repeat ultrasound testing a week after an initial normal test. Less ultrasound testing will be performed because: i) more patients will have deep vein thrombosis excluded by combinations of Clinical Pretest Probability and D-dimer results on the day of presentation; and, ii) in those who still need an ultrasound, a repeat ultrasound a week after a normal result will only be performed if the D-dimer result is markedly abnormal at initial presentation. 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Ultrasound | Low Clinical Pretest Probability and D-dimer < 1000 ug/L; Moderate Clinical Pretest Probability and D-dimer < 500 ug/L | ||
| Ultrasound Required | Low Clinical Pretest Probability and D-dimer 1000 - 3000 ug/L; Moderate Clinical Pretest Probability and D-dimer 500 - 3000 ug/L; High Clinical Pretest Probability |
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| Measure | Description | Time Frame |
|---|---|---|
| Confirmed symptomatic proximal Deep Vein Thrombosis | The primary outcome is confirmed symptomatic proximal Deep Vein Thrombosis (including involvement of the calf vein trifurcation but not isolated more distal Deep Vein Thrombosis; or pulmonary embolism (not including isolated sub-segmental abnormalities on Computed Tomography Pulmonary Angiogram; within 90 days (± 7 days for follow-up assessment) that is not diagnosed by scheduled diagnostic testing (includes events that occur between initial and scheduled follow-up proximal ultrasound examinations). | within 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pretest Probability/ D-dimer/ Compression Ultrasound subgroups | The primary outcome in the following subgroups:
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Inclusion Criteria:
1) Consecutive outpatients (i.e. non-hospitalized patients) with clinically suspected Deep Vein Thrombosis.
Exclusion Criteria:
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Male and females outpatients with a suspected Deep Vein Thrombosis
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| Name | Affiliation | Role |
|---|---|---|
| Mark Levine, MD | ocog | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada | ||
| Nova Scotia Cancer Centre |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| within 90 days |
| Death | Death within 90 days (± 7 days for follow-up assessment). | within 90 days |
| Halifax |
| Nova Scotia |
| B3H1V7 |
| Canada |
| Hamilton Health Sciences - Hamilton General | Hamilton | Ontario | L8L 2X2 | Canada |
| Hamilton Health Sciences - McMaster | Hamilton | Ontario | L8N 3Z5 | Canada |
| St. Joseph's Healthcare | Hamilton | Ontario | L8N 4A6 | Canada |
| Juravinski Cancer Hospital | Hamilton | Ontario | L8V1C3 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| The Ottawa Hospital Regional Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| The Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1G2EB | Canada |