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Safety of a Diagnostic Strategy With D-Dimer Testing for PE

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: NCT00182221
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 30, 2017
Heart and Stroke Foundation of Ontario
Information provided by:
McMaster University

Brief Summary:

To determine whether D-Dimer testing, using the MDA D-Dimer assay, can be used to simplify the diagnostic process for pulmonary embolism (PE). This will be assessed by performing a cohort study in 1000 patients with suspected PE.

To ascertain if an MDA D-Dimer result of less than 0.75 ug/mL FEU obviates the need for further testing and therapy in patients with suspected PE.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Procedure: MDA D-Dimer Testing Phase 3

Detailed Description:
Prospective cohort study of 1000 patients in which those with a negative D-Dimer result undergo no further testing and are followed for 3 months for venous thromboembolism. Patients with a positive D-Dimer undergo standardized testing.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer Testing in Patients With Suspected Pulmonary Embolism
Study Start Date : August 2003
Primary Completion Date : February 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Venousthromboembolism [ Time Frame: 3 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age 18 years or older
  • Suspected PE

Exclusion Criteria:

  • Treatment with full-dose anticoagulants for 24 hours or more OR an ongoing requirement for anticoagulants
  • Other tests for PE performed prior to eligibility assessment (e.g.other D-Dimer, V/Q scan, pulmonary angiogram, spiral CT, compression ultrasound, venogram).
  • Cardiorespiratory instability requiring immediate performance of other tests to diagnose or exclude PE (i.e. inability to wait 30-60 minutes for MDA D-Dimer result)
  • Comorbid condition limiting survival to less than three months
  • Patient has been asymptomatic for seven days prior to presentation
  • Current pregnancy
  • Contraindication to contrast (e.g., allergy, renal failure).
  • Geographic in accessibility which precludes follow-up
  • Presence of central venous catheter (permanent or temporary, including PICC line) at the time of eligibility 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): NCT00182221

Canada, Ontario
St Joseph's Health Care Centre
Hamilton, Ontario, Canada, L8N 4A6
Hamilton Health Sciences-Henderson Campus
Hamilton, Ontario, Canada, L8V !C3
Hamilton Health Sciences-McMaster Campus
Hamilton, Ontario, Canada, L8V 1C3
Hamilton Health Sciences, General
Hamilton, Ontario, Canada
Sponsors and Collaborators
McMaster University
Heart and Stroke Foundation of Ontario
Principal Investigator: Shannon M Bates, MDCM,MSc Hamilton Health Sciences Corporation Identifier: NCT00182221     History of Changes
Other Study ID Numbers: CTMG-2005-SIMPLE
Grant #NA 5154
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by McMaster University:
Pulmonary Embolism
Deep Vein Thrombosis
MDA D-Dimer Testing
Diagnostic Algorithm

Additional relevant MeSH terms:
Venous Thromboembolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action