MDA D-Dimer / Recurrent DVT 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: NCT00157599
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 26, 2011
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University

Brief Summary:
To determine whether treatment and further investigation can be safely withheld in patients who present with suspected recurrent deep vein thrombosis (DVT) and have either a (i) negative D-Dimer or (ii) a positive D-Dimer with normal serial compression ultrasound.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Procedure: various diagnostic measures for DVT (e.g., CUS) Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer and Compression Ultrasonography in Patients With Suspected Recurrent Deep Vein Thrombosis
Study Start Date : January 2002
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Suspected DVT during follow-up
  2. Suspected PE during follow-up

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 or older
  • Currently suspected for recurrent DVT
  • Has a prior history of objectively documented DVT or PE

Exclusion Criteria:

  • Comorbid condition limiting survival to less than 3 months
  • History of hypersensitivity to contrast medium
  • Renal dysfunction with a creatinine of > 150 mcmol/L
  • Treatment with full-dose therapeutic unfractionated or low molecular weight heparin that was initiated 24 hours or more prior to eligibility assessment
  • Pregnancy or lactation
  • Symptomatic for pulmonary embolism
  • Absence of symptoms within five days prior to presentation
  • Participation in another trial precluding the use of the diagnostic algorithm in this study
  • Geographically inaccessible for follow-up
  • Compression ultrasound, venogram, IPG, or D-dimer performed PRIOR to assessment

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): NCT00157599

Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
Henderson Research Centre
Hamilton, Ontario, Canada, L8V 1C3
Canada, Quebec
Sir Mortimer B. Davis Jewish General
Montreal, Quebec, Canada, H3T 1E2
Academic Medical Centre
Amsterdam, Netherlands
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Shannon Bates, M.D. McMaster University Identifier: NCT00157599     History of Changes
Other Study ID Numbers: CTMG-2002-MDA
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: October 2007

Keywords provided by McMaster University:
deep vein thrombosis

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