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

Completed

• Conditions: Cancer; Pulmonary Embolism
• Interventions: Procedure: CT pulmonary angiogram and d-dimer draw

• Registration Number: NCT00615147
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-14
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-06
• Last Update Posted: 2012-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	CT pulmonary angiogram and d-dimer draw	Patients to have a CT pulmonary angiogram for suspected pulmonary embolism will have a d-dimer drawn as is routinely done.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States