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D-Dimer Vs Serial Compression Ultrasound Study

This study has been completed.
Sponsor:
Collaborator:
Health Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182351
First received: September 13, 2005
Last updated: September 7, 2006
Last verified: September 2006
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182351

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

Publications:

ClinicalTrials.gov Identifier: NCT00182351     History of Changes
Other Study ID Numbers: CTMG-1995-DDCUS
Study First Received: September 13, 2005
Last Updated: September 7, 2006
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrin fragment D
Antifibrinolytic Agents
 Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013