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MDA D-Dimer / Recurrent DVT Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00157599
First Posted: September 12, 2005
Last Update Posted: July 26, 2011
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.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University
  Purpose
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 Intervention
Deep Vein Thrombosis Procedure: various diagnostic measures for DVT (e.g., CUS)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Suspected DVT during follow-up
  • Suspected PE during follow-up

Estimated Enrollment: 500
Study Start Date: January 2002
Estimated Study Completion Date: March 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  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): NCT00157599


Locations
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
Netherlands
Academic Medical Centre
Amsterdam, Netherlands
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Shannon Bates, M.D. McMaster University
  More Information

ClinicalTrials.gov Identifier: NCT00157599     History of Changes
Other Study ID Numbers: CTMG-2002-MDA
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: July 26, 2011
Last Verified: October 2007

Keywords provided by McMaster University:
deep vein thrombosis
DVT

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
Hemostatics
Coagulants