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

March 28, 2017 updated by: McMaster University

A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer Testing in Patients With Suspected Pulmonary Embolism

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton Health Sciences, General
      • Hamilton, Ontario, Canada, L8N 4A6
        • St Joseph's Health Care Centre
      • Hamilton, Ontario, Canada, L8V !C3
        • Hamilton Health Sciences-Henderson Campus
      • Hamilton, Ontario, Canada, L8V 1C3
        • Hamilton Health Sciences-McMaster Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Venousthromboembolism
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Heart and Stroke Foundation of Ontario

Investigators

  • Principal Investigator: Shannon M Bates, MDCM,MSc, Hamilton Health Sciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMG-2005-SIMPLE
  • Grant #NA 5154

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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