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The Designer D-dimer Deep Vein Thrombosis Diagnosis (4D) Study (4D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02038530
Recruitment Status : Active, not recruiting
First Posted : January 16, 2014
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University

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
Suspected Deep Vein Thrombosis

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.

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Study Type : Observational
Actual Enrollment : 1513 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: D-dimer Testing, Tailored to Clinical Pretest Probability, to Minimize Initial and Follow-up Ultrasound Imaging in Suspected Deep Vein Thrombosis: A Management Study
Study Start Date : February 2014
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Confirmed symptomatic proximal Deep Vein Thrombosis [ Time Frame: 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 :
  1. Clinical Pretest Probability/ D-dimer/ Compression Ultrasound subgroups [ Time Frame: 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

  2. Death [ Time Frame: within 90 days ]
    Death within 90 days (± 7 days for follow-up assessment).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and females outpatients with a suspected Deep Vein Thrombosis
Criteria

Inclusion Criteria:

1) Consecutive outpatients (i.e. non-hospitalized patients) with clinically suspected Deep Vein Thrombosis.

Exclusion Criteria:

  1. Age less than 18 years.
  2. Treated with full-dose anticoagulation for ≥ 24 hours before D-dimer was measured.
  3. D-dimer level known before Clinical Pretest Probability documented.
  4. Ultrasound of the leg performed before Clinical Pretest Probability was documented
  5. 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).
  6. Ongoing need for anticoagulant therapy.
  7. Suspected Pulmonary Embolism.
  8. Superficial venous thrombosis that requires, or may require, anticoagulant therapy.
  9. Life expectancy less than 3 months.
  10. Previously confirmed episode of Deep Vein Thrombosis.
  11. Geographic inaccessibility which precludes follow-up.
  12. Known pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038530


Locations
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Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H1V7
Canada, Ontario
Hamilton Health Sciences - Hamilton General
Hamilton, Ontario, Canada, L8L 2X2
Hamilton Health Sciences - McMaster
Hamilton, Ontario, Canada, L8N 3Z5
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Juravinski Cancer Hospital
Hamilton, Ontario, Canada, L8V1C3
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
The Ottawa Hospital Regional Centre
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
The Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1G2EB
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Clive Kearon, MD OCOG
Additional Information:
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02038530    
Other Study ID Numbers: OCOG-2013-4D
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Keywords provided by McMaster University:
Deep Vein Thrombosis
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases