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D-Dimer Vs Serial Compression Ultrasound Study

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ClinicalTrials.gov Identifier: NCT00182351
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 8, 2006
Information provided by:

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Procedure: D-dimer Procedure: Serial Compression Ultrasound Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Safety, Efficacy and Cost-Effectiveness of Two Strategies for the Diagnosis of Deep Vein Thrombosis
Study Start Date : April 1996
Estimated Study Completion Date : July 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. safety of withholding anticoagulants

Secondary Outcome Measures :
  1. deep vein thrombosis
  2. pulmonary embolism
  3. death

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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): NCT00182351

Canada, Ontario
Hamilton Health Sciences - Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
Hamilton Health Sciences - Henderson Hospital
Hamilton, Ontario, Canada, L8V 1C3
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Health Canada
Study Chair: Clive Kearon, MB Hamilton Health Sciences and McMaster University
More Information

ClinicalTrials.gov Identifier: NCT00182351     History of Changes
Other Study ID Numbers: CTMG-1995-DDCUS
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 8, 2006
Last Verified: September 2006

Keywords provided by McMaster University:
deep vein thrombosis
serial compression ultrasound

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action