NCT03532165|Unknown
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Sponsor study identifier
interventional
300
1 country
1
Study Start
April 2, 2018
Actual (reported)Primary Completion
February 22, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
At most institutions, the average patient with clinical concern for PE(pulmonary embolism) will have a CT angiogram(CTA) with contrast of the lungs performed to evaluate for a clot. However, CTA has risks including contrast- induced allergic reactions and nephropathy, as well as radiation which has been linked to development of cancer later in life. There is literature that has looked at using lower extremity doppler ultrasound first to evaluate for a DVT (deep venous thrombosis) in patients where there is concern for a PE. There is also literature showing that emergency medicine physicians can perform adequate lower extremity compression ultrasounds (LCUS), at the bedside with results similar to that of the ultrasound tech. The goal of this project is to fuse both principles by having emergency medicine physicians perform LCUS at the bedside, to help reduce CTA utilization in the evaluation of PE.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2, 2018
Actual (reported)May 1, 2018
Actual (reported)May 22, 2018
Actual (reported)February 22, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Absolute reduction in CT imaging to diagnose PE
With the use of lower extremity ultrasound to diagnose DVT, some patients may forego the need for CT imaging while receiving appropriate care/treatment.
for duration of the study,about 1 year
Potential reduction in CT imaging to diagnose PE
for duration of the study, about 1 year
Time to start of treatment
for duration of the study , about 1 year
Cost-analysis
for duration of study, about 1 year
This group found to to have a deep venous thrombosis on lower extremity ultrasound will not have a CT of the chest ordered from the emergency department, and will be treated for the DVT and presumed PE.
This group that does not have a deep venous thrombosis on lower extremity ultrasound will proceed to get the CT of the chest .
One group may forego a CT angiogram of the chest if they have a positive lower extremity ultrasound. The other group with a negative ultrasound may still require CT angiogram imaging.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Albany Medical Center Department of Emergency Medicine
Albany, New York, 12208, United States
Skinner S. Pulmonary embolism: assessment and imaging. Aust Fam Physician. 2013 Sep;42(9):628-32.
Da Costa Rodrigues J, Alzuphar S, Combescure C, Le Gal G, Perrier A. Diagnostic characteristics of lower limb venous compression ultrasonography in suspected pulmonary embolism: a meta-analysis. J Thromb Haemost. 2016 Sep;14(9):1765-72. doi: 10.1111/jth.13407. Epub 2016 Aug 17.
Perrier A, Roy PM, Aujesky D, Chagnon I, Howarth N, Gourdier AL, Leftheriotis G, Barghouth G, Cornuz J, Hayoz D, Bounameaux H. Diagnosing pulmonary embolism in outpatients with clinical assessment, D-dimer measurement, venous ultrasound, and helical computed tomography: a multicenter management study. Am J Med. 2004 Mar 1;116(5):291-9. doi: 10.1016/j.amjmed.2003.09.041.
Dorcas B Pinto, MD
Albany Medical College
First Submitted
May 1, 2018
First Posted
May 22, 2018
Study Start
Contact the study team to confirm eligibility.
Poley RA, Newbigging JL, Sivilotti ML. Estimated effect of an integrated approach to suspected deep venous thrombosis using limited-compression ultrasound. Acad Emerg Med. 2014 Sep;21(9):971-80. doi: 10.1111/acem.12459.
April 2, 2018
Actual (reported)Primary Completion
February 22, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 22, 2018
Record last verified: 2018-05
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