The Designer D-dimer Deep Vein Thrombosis Diagnosis (4D) Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Ultrasound Low Clinical Pretest Probability and D-dimer < 1000 ug/L; Moderate Clinical Pretest Probability and D-dimer < 500 ug/L |
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| 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 |
Outcome Measures
Primary Outcome Measures
- Confirmed symptomatic proximal Deep Vein Thrombosis [within 90 days]
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).
Secondary Outcome Measures
- Clinical Pretest Probability/ D-dimer/ Compression Ultrasound subgroups [within 90 days]
The primary outcome in the following subgroups: Low Clinical Pretest Probability and D-dimer <1000 ug/L Moderate Clinical Pretest Probability and D-dimer <500 ug/L Moderate Clinical Pretest Probability and D-dimer 500 -999 ug/L High Clinical Pretest Probability and D-dimer <500 ug/L Low Clinical Pretest Probability and D-dimer 1000-2999 ug/L and negative initial ultrasound Moderate Clinical Pretest Probability and D-dimer 1000-2999 ug/L and negative initial ultrasound High Clinical Pretest Probability and D-dimer 500-1499 ug/L and negative initial ultrasound
- Death [within 90 days]
Death within 90 days (± 7 days for follow-up assessment).
Eligibility Criteria
Criteria
Inclusion Criteria:
- Consecutive outpatients (i.e. non-hospitalized patients) with clinically suspected Deep Vein Thrombosis.
Exclusion Criteria:
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Age less than 18 years.
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Treated with full-dose anticoagulation for ≥ 24 hours before D-dimer was measured.
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D-dimer level known before Clinical Pretest Probability documented.
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Ultrasound of the leg performed before Clinical Pretest Probability was documented
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Ultrasound was or will be performed in a patient with low Clinical Pretest Probability and a d-dimer <1000(or equivalent), or with Moderate Clinical Pretest Probability and a D-dimer <500 (or equivalent) (e.g. suspected bleeding).
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Ongoing need for anticoagulant therapy.
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Suspected Pulmonary Embolism.
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Superficial venous thrombosis that requires, or may require, anticoagulant therapy.
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Life expectancy less than 3 months.
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Previously confirmed episode of Deep Vein Thrombosis.
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Geographic inaccessibility which precludes follow-up.
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Known pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 2B7 |
| 2 | Nova Scotia Cancer Centre | Halifax | Nova Scotia | Canada | B3H1V7 |
| 3 | Hamilton Health Sciences - Hamilton General | Hamilton | Ontario | Canada | L8L 2X2 |
| 4 | Hamilton Health Sciences - McMaster | Hamilton | Ontario | Canada | L8N 3Z5 |
| 5 | St. Joseph's Healthcare | Hamilton | Ontario | Canada | L8N 4A6 |
| 6 | Juravinski Cancer Hospital | Hamilton | Ontario | Canada | L8V1C3 |
| 7 | London Health Sciences Centre | London | Ontario | Canada | N6A 5W9 |
| 8 | The Ottawa Hospital Regional Centre | Ottawa | Ontario | Canada | K1H 8L6 |
| 9 | The Jewish General Hospital | Montreal | Quebec | Canada | H3T 1E2 |
| 10 | Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | Canada | J1G2EB |
Sponsors and Collaborators
- McMaster University
- Canadian Institutes of Health Research (CIHR)
Investigators
- Study Director: Mark Levine, MD, ocog
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- OCOG-2013-4D