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

Suspected Deep Vein Thrombosis Clinical Trial

— 4D  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038530
• Other study ID #: OCOG-2013-4D
• Status: Completed
• Start date: February 2014
• Est. completion date: October 15, 2020

Study information

• Verified date: September 2021
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1513
• Est. completion date: October 15, 2020
• Est. primary completion date: June 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Suspected Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences - Hamilton General	Hamilton	Ontario
Canada	Hamilton Health Sciences - McMaster	Hamilton	Ontario
Canada	Juravinski Cancer Hospital	Hamilton	Ontario
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	The Jewish General Hospital	Montreal	Quebec
Canada	The Ottawa Hospital Regional Centre	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Clinical Pretest Probability/ D-dimer/ Compression Ultrasound subgroups	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	within 90 days
Secondary	Death	Death within 90 days (± 7 days for follow-up assessment).	within 90 days

External Links

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