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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00182221

Enrollment

1000

Registered

2005-09-16

Start date

2003-08-31

Completion date

2008-04-30

Last updated

2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Keywords

Pulmonary Embolism, Deep Vein Thrombosis, MDA D-Dimer Testing, Diagnostic Algorithm

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.

Interventions

PROCEDUREMDA D-Dimer Testing

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Venousthromboembolism	3 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026