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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615147
• Other study ID #: 05-040
• Status: Completed
• Phase: N/A
• First received: February 1, 2008
• Last updated: January 6, 2012
• Start date: May 2005
• Est. completion date: June 2008

Study information

• Verified date: January 2012
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Embolism
• Pulmonary Embolism

Intervention

Procedure:
• CT pulmonary angiogram and d-dimer draw
A CT pulmonary angiogram and a d-dimer drawn within 24 hours.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To estimate the positive predictive value, sensitivity, and specificity of the d-dimer assay relative to CT pulmonary angiogram.		conclusion of study	No
Secondary	To explore the association between the accuracy of the d-dimer assay and clinical symptoms indicating pulmonary embolism.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center