Sonography Outcomes Assessment Program for Lower Extremity Deep Venous Thrombosis
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|ClinicalTrials.gov Identifier: NCT00178789|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 23, 2007
Currently, most emergency physicians have limited access to obtaining formal radiology ultrasound studies, particularly overnight. Many are forced to adopt risky and expensive strategies in managing their patients with suspected deep venous thrombosis (DVT) who present during off-hours: for low risk patients, discharging without anticoagulation and arranging for outpatient studies; for moderate to high risk patients, empirically anticoagulating and admitting to the hospital to await definitive testing. If emergency physicians could reliably perform an accurate ultrasound exam for DVT, such risks could be obviated.
This is a prospective, observational cohort study assessing the accuracy of emergency physician diagnosis of proximal DVT using compact ultrasound equipment and a simplified compression technique. The value of color flow doppler and augmentation will also be assessed. Outcomes (sensitivity, specificity, positive likelihood ratio and negative likelihood ratio) will be assessed at 30 days.
Prior to enrolling patients in the study, emergency physicians will undertake a 2 hour training course on the performance of the simplified compression technique for the diagnosis of lower extremity DVT. Emergency physicians will perform the DVT ultrasound exam on study subjects with suspected DVT. Clinical management of the study subjects will not be altered; all subjects will proceed to receive a formal DVT ultrasound study by the radiology department which will serve as the criterion reference for the study.
|Condition or disease||Phase|
|Deep Venous Thrombosis||Phase 1 Phase 2|
|Study Type :||Observational|
|Estimated Enrollment :||51 participants|
|Official Title:||Prospective Observational Trial of Point-of-Care, Limited Ultrasonography (PLUS) for Lower Extremity Deep Venous Thrombosis in the Emergency Department: The Sonography Outcomes Assessment Program (SOAP-4 Trial)|
|Study Start Date :||September 2005|
|Study Completion Date :||May 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178789
|United States, Texas|
|Memorial Hermann Hospital Emergency Department|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gregory M Press, MD||The University of Texas Health Science Center, Houston|