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

Phase 3

Completed

• Conditions: Venous Thromboembolism

• Registration Number: NCT00182221
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2008-02
• Study Completion: 2008-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Venousthromboembolism	3 months

Trial Locations

Locations (4)

Hamilton Health Sciences, General; 🇨🇦 Hamilton, Ontario, Canada

Hamilton Health Sciences-Henderson Campus; 🇨🇦 Hamilton, Ontario, Canada

Hamilton Health Sciences-McMaster Campus; 🇨🇦 Hamilton, Ontario, Canada

St Joseph's Health Care Centre; 🇨🇦 Hamilton, Ontario, Canada