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

McMaster University

Status and phase

Completed

Phase 3

Conditions

Venous Thromboembolism

Treatments

Procedure: MDA D-Dimer Testing

Study type

Interventional

Funder types

Other

Identifiers

NCT00182221

CTMG-2005-SIMPLE

Grant #NA 5154

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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