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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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MDA D-Dimer Testing

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No