D-Dimer Vs Serial Compression Ultrasound Study

Deep Vein Thrombosis Clinical Trial

Official title:

Evaluation of the Safety, Efficacy and Cost-Effectiveness of Two Strategies for the Diagnosis of Deep Vein Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182351
• Other study ID #: CTMG-1995-DDCUS
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 7, 2006
• Start date: April 1996
• Est. completion date: July 1999

Study information

• Verified date: September 2006
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

To determine whether d-dimer testing can be used to simplify and reduce the costs of the diagnostic approach to patients with clinically suspected deep vein thrombosis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 810
• Est. completion date: July 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• first suspected deep vein thrombosis

• no previous venous thromboembolism

• referred to thromboembolism outpatient clinic

Exclusion Criteria:

• comorbid condition limiting survival to less than six months

• contraindication to venography (contrast allergy, etc.)

• receiving long term warfarin therapy

• receiving full dose heparin therapy for more than 48 hours

• absence of symptoms during the five days immediately prior to presentation

• symptoms of pulmonary embolism

• pregnancy

• geographic inaccessibility which precludes follow-up

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• D-dimer

• Serial Compression Ultrasound

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences - Hamilton General Hospital	Hamilton	Ontario
Canada	Hamilton Health Sciences - Henderson Hospital	Hamilton	Ontario
Canada	St. Joseph's Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Health Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Kearon C, Ginsberg JS, Douketis J, Crowther MA, Turpie AG, Bates SM, Lee A, Brill-Edwards P, Finch T, Gent M. A randomized trial of diagnostic strategies after normal proximal vein ultrasonography for suspected deep venous thrombosis: D-dimer testing comp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety of withholding anticoagulants
Secondary	deep vein thrombosis
Secondary	pulmonary embolism
Secondary	death