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D-Dimer Vs Serial Compression Ultrasound Study

This study has been completed.
Health Canada
Information provided by:
McMaster University Identifier:
First received: September 13, 2005
Last updated: September 7, 2006
Last verified: September 2006
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 Intervention Phase
Deep Vein Thrombosis Procedure: D-dimer Procedure: Serial Compression Ultrasound Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • safety of withholding anticoagulants

Secondary Outcome Measures:
  • deep vein thrombosis
  • pulmonary embolism
  • death

Estimated Enrollment: 810
Study Start Date: April 1996
Estimated Study Completion Date: July 1999

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
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Please refer to this study by its identifier: 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

Publications: Identifier: NCT00182351     History of Changes
Other Study ID Numbers: CTMG-1995-DDCUS
Study First Received: September 13, 2005
Last Updated: September 7, 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
Coagulants processed this record on August 22, 2017