Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population

Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population: A Correlation With Ct Pulmonary Angiogram in the Urgent Care Setting

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00615147

Enrollment

213

Registered

2008-02-14

Start date

2005-05-31

Completion date

2008-06-30

Last updated

2012-01-09

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

Conditions

Cancer, Pulmonary Embolism

Keywords

Any cancer, suspected pulmonary embolism

Brief summary

The purpose of this study is to see if a blood test (D-dimer) is as precise as the CT scan for the detection of clots. A pulmonary embolism is an obstruction of the blood vessels in your lungs usually due to a blood clot that travels to the lungs usually from the leg. Research has shown that the results of a specific blood test (D-dimer) can be used instead of a CT scan to diagnose clots. D-dimer is a valuable diagnostic marker in either detecting the presence of or monitoring the progress of blood clots. D-dimer assays have proven to be a beneficial diagnostic tool in the evaluation of patients with suspected pulmonary embolism (PE).

Interventions

PROCEDURECT pulmonary angiogram and d-dimer draw

A CT pulmonary angiogram and a d-dimer drawn within 24 hours.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* All patients evaluated in the urgent care center and determined to need with CT pulmonary angiogram to rule out pulmonary embolism based on signs and symptoms such as dyspnea, pleuritic chest pain, tachycardia, and/or pulse oxygen desaturation will be included.

Exclusion criteria

* Inability to obtain CT pulmonary angiogram secondary to lack of IV access, contrast allergy or lack of consent. * CT pulmonary angiogram not done with routine protocol for rule out pulmonary embolism. * Less than 21 years of age

Design outcomes

Primary

Measure	Time frame
The negative predictive value of the d-dimer assay relative to CT pulmonary angiogram will be the primary measure of accuracy used for this purpose.	conclusion of study

Secondary

Measure	Time frame
To estimate the positive predictive value, sensitivity, and specificity of the d-dimer assay relative to CT pulmonary angiogram.	conclusion of study
To explore the association between the accuracy of the d-dimer assay and clinical symptoms indicating pulmonary embolism.	conclusion of study

Countries

United States

Outcome results

None listed

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