ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Sonography Outcomes Assessment Program for Lower Extremity Deep Venous Thrombosis

This study has been completed.
Study NCT00178789.   Last updated on May 22, 2007.   Information provided by The University of Texas Health Science Center, Houston

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Sonography Outcomes Assessment Program for Lower Extremity Deep Venous Thrombosis
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)
Brief Summary

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.

Detailed Description
Study Phase Phase I, Phase II
Study Type  Observational
Study Design  Screening, Cross-Sectional, Random Sample, Prospective Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Deep Venous Thrombosis
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  51
Start Date  September 2005
Completion Date May 2007
Eligibility Criteria 

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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00178789
Organization ID HSC-MS-05-0011
Secondary IDs ††
Study Sponsor  The University of Texas Health Science Center, Houston
Collaborators ††
Investigators 
Principal Investigator:     Gregory M Press, MD     The University of Texas Health Science Center, Houston    
Information Provided By The University of Texas Health Science Center, Houston
Verification Date May 2007
First Received Date  September 13, 2005
Last Updated Date May 22, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers