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Sonography Outcomes Assessment Program for Lower Extremity Deep Venous Thrombosis
This study has been completed.
Study NCT00178789   Information provided by The University of Texas Health Science Center, Houston
First Received: September 13, 2005   Last Updated: May 22, 2007   History of Changes

September 13, 2005
May 22, 2007
September 2005
 
 
 
Complete list of historical versions of study NCT00178789 on ClinicalTrials.gov Archive Site
 
 
 
Sonography Outcomes Assessment Program for Lower Extremity Deep Venous Thrombosis
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)

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.

 
Phase I, Phase II
Observational
Screening, Cross-Sectional, Random Sample, Prospective Study
Deep Venous Thrombosis
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
51
May 2007
 

Inclusion Criteria:

  • Inclusion criteria:

    1. Presenting signs and symptoms sufficiently suspicious for lower extremity DVT to warrant a formal radiology study in the opinion of the treating physician AND EITHER 2a. Moderate or high pre-test clinical probability of DVT (Wells Criteria) OR 2b. Low pre-test clinical probability of DVT with a positive D-dimer

Exclusion Criteria:

  • Exclusion criteria:

    1. Documented lower extremity DVT within the past 60 days
    2. Anatomic abnormality that, in the judgment of the investigator, would preclude imaging of both femoral and popliteal veins on the affected leg (i.e. above-knee amputation or severe scarring from intravenous drug abuse in the inguinal area)
    3. Patient below the age of 18 years.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00178789
 
HSC-MS-05-0011
The University of Texas Health Science Center, Houston
 
Principal Investigator: Gregory M Press, MD The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP