D-Dimer Vs Serial Compression Ultrasound Study

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. Identifier: NCT00182351
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 8, 2006
Health Canada
Information provided by:
McMaster University

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 Type : Interventional  (Clinical Trial)
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
Study Completion Date : July 1999

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. safety of withholding anticoagulants

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

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 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

Publications of Results: 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