Sonography Outcomes Assessment Program for Lower Extremity Deep Venous Thrombosis

This study has been completed.
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178789
First received: September 13, 2005
Last updated: May 22, 2007
Last verified: May 2007
  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.


Condition Phase
Deep Venous Thrombosis
Phase 1
Phase 2

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Cross-Sectional
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)

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Estimated Enrollment: 51
Study Start Date: September 2005
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178789

Locations
United States, Texas
Memorial Hermann Hospital Emergency Department
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Gregory M Press, MD The University of Texas Health Science Center, Houston
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00178789     History of Changes
Other Study ID Numbers: HSC-MS-05-0011
Study First Received: September 13, 2005
Last Updated: May 22, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
Deep Venous Thrombosis
Blood Clot
Lower Extremity
Sonography

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on August 28, 2014