Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population
1 other identifier
observational
213
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2005
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJanuary 9, 2012
January 1, 2012
3.1 years
February 1, 2008
January 6, 2012
Conditions
Keywords
Outcome Measures
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.
conclusion of study
Secondary Outcomes (2)
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
Study Arms (1)
1
Patients to have a CT pulmonary angiogram for suspected pulmonary embolism will have a d-dimer drawn as is routinely done.
Interventions
A CT pulmonary angiogram and a d-dimer drawn within 24 hours.
Eligibility Criteria
Patients coming to MSKCC Urgent care unit
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2008
First Posted
February 14, 2008
Study Start
May 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
January 9, 2012
Record last verified: 2012-01