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Completed

NCT Number: NCT00615147

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

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).

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Key information

Conditions

Cancer Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Neoplasms Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT pulmonary angiogram and d-dimer draw

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. To estimate the positive predictive value, sensitivity, and specificity of the d-dimer assay relative to CT pulmonary angiogram.

    Time frame: conclusion of study

  2. To explore the association between the accuracy of the d-dimer assay and clinical symptoms indicating pulmonary embolism.

    Time frame: conclusion of study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Feb 14, 2008
Registry last updated
Jan 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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