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| Sponsor: | The University of Texas Health Science Center, Houston |
|---|---|
| Information provided by: | The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT00178789 |
Purpose
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.
| Study Type: | Observational |
| Study Design: | Screening, Cross-Sectional, Random Sample, Prospective Study |
| 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) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion criteria:
Exclusion Criteria:
Exclusion criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | HSC-MS-05-0011 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 22, 2007 |
| ClinicalTrials.gov Identifier: | NCT00178789 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Deep Venous Thrombosis Blood Clot Lower Extremity Sonography |
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Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Venous Thrombosis Thrombosis |