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

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00615147

Purpose

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).

Condition	Intervention
Cancer Pulmonary Embolism	Procedure: CT pulmonary angiogram and d-dimer draw

MedlinePlus related topics: Cancer Pulmonary Embolism

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To estimate the positive predictive value, sensitivity, and specificity of the d-dimer assay relative to CT pulmonary angiogram. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
To explore the association between the accuracy of the d-dimer assay and clinical symptoms indicating pulmonary embolism. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	213
Study Start Date:	May 2005
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients to have a CT pulmonary angiogram for suspected pulmonary embolism will have a d-dimer drawn as is routinely done.	Procedure: CT pulmonary angiogram and d-dimer draw A CT pulmonary angiogram and a d-dimer drawn within 24 hours.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients coming to MSKCC Urgent care unit

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615147

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Michelle Ginsberg, MD )
Study ID Numbers:	05-040
Study First Received:	February 1, 2008
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00615147
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Any cancer
suspected pulmonary embolism

Study placed in the following topic categories:

Antiplasmin
Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism

Lung Diseases
Vascular Diseases
Fibrin fragment D
Thrombosis

Additional relevant MeSH terms:

Fibrin Modulating Agents
Antifibrinolytic Agents
Coagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Cardiovascular Diseases
Hemostatics
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009