MDA D-Dimer / Recurrent DVT Study

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00157599
First received: September 7, 2005
Last updated: July 25, 2011
Last verified: October 2007
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157599

Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Henderson Research Centre
Hamilton, Ontario, Canada, L8V 1C3
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
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

No publications provided

ClinicalTrials.gov Identifier: NCT00157599     History of Changes
Other Study ID Numbers: CTMG-2002-MDA
Study First Received: September 7, 2005
Last Updated: July 25, 2011
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
deep vein thrombosis
DVT

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014