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

This study has been completed.
Heart and Stroke Foundation of Ontario
Information provided by:
McMaster University Identifier:
First received: September 13, 2005
Last updated: March 28, 2017
Last verified: March 2017

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 Intervention Phase
Venous Thromboembolism
Procedure: MDA D-Dimer Testing
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Venousthromboembolism [ Time Frame: 3 months ]

Estimated Enrollment: 1000
Study Start Date: August 2003
Study Completion Date: April 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
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.

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
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Please refer to this study by its identifier: 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
  More Information Identifier: NCT00182221     History of Changes
Other Study ID Numbers: CTMG-2005-SIMPLE
Grant #NA 5154
Study First Received: September 13, 2005
Last Updated: March 28, 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
Coagulants processed this record on April 26, 2017