Safety of a Diagnostic Strategy With D-Dimer Testing for PE
A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer Testing in Patients With Suspected Pulmonary Embolism
2 other identifiers
interventional
1,000
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2003
Longer than P75 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedMarch 30, 2017
March 1, 2017
4.5 years
September 13, 2005
March 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Venousthromboembolism
3 months
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Suspected PE
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- Heart and Stroke Foundation of Ontariocollaborator
Study Sites (4)
St Joseph's Health Care Centre
Hamilton, Ontario, L8N 4A6, Canada
Hamilton Health Sciences-Henderson Campus
Hamilton, Ontario, L8V !C3, Canada
Hamilton Health Sciences-McMaster Campus
Hamilton, Ontario, L8V 1C3, Canada
Hamilton Health Sciences, General
Hamilton, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon M Bates, MDCM,MSc
Hamilton Health Sciences Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
August 1, 2003
Primary Completion
February 1, 2008
Study Completion
April 1, 2008
Last Updated
March 30, 2017
Record last verified: 2017-03