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

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182221
First received: September 13, 2005
Last updated: April 18, 2008
Last verified: April 2008
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00182221

Locations
Canada, Ontario
Hamilton Health Sciences, General
Hamilton, Ontario, Canada
Hamilton Health Sciences-Henderson Campus
Hamilton, Ontario, Canada, L8V !C3
Hamilton Health Sciences-McMaster Campus
Hamilton, Ontario, Canada, L8V 1C3
St Joseph's Health Care Centre
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Shannon M Bates, MDCM,MSc Hamilton Health Sciences Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00182221     History of Changes
Other Study ID Numbers: CTMG-2005-SIMPLE, Grant #NA 5154
Study First Received: September 13, 2005
Last Updated: April 18, 2008
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 21, 2014