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OpenTrials
Completed

NCT Number: NCT01007045

Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis

Deep vein thrombosis is a common condition seen in the Emergency Department. Standard of care for diagnosis of DVT includes a combination of a clinical pre-test probability rule known as Well's criteria, D-dimer blood testing, and Radiology department ultrasound.

The purpose of this study is to determine whether Emergency Physicians can safely rule out deep vein thrombosis using Well's criteria and D-dimer blood testing combined with Emergency department bedside ultrasound.

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hotel Dieu Hospital, Kingston, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 16 years
  • Clinically suspected lower extremity DVT

Exclusion criteria

  • Known chronic DVT
  • Acute DVT confirmed by prior formal imaging
  • Inability to assess common femoral or popliteal area (due to cast, above knee amputation, etc.)
  • Anticoagulation >48 hours prior to imaging (formal or LCU)

Treatment and study plan

Primary outcomes

  1. First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients.

    Time frame: 3 days

  2. Second co-primary outcome: sensitivity/specificity of LC U/S plus D-dimer vs formal ultrasound in clinically "likely" DVT patients.

    Time frame: 3 days

Secondary outcomes

  1. interobserver reliability of modified Well's criteria

    Time frame: 3 days

  2. learning curve for LC U/S by emergency physicians and residents

    Time frame: 365 days

  3. difference in diagnostic time interval for patients grouped by pre-test probability

    Time frame: 3 days

  4. number of return visits for formal ultrasound imaging

    Time frame: 3 days

  5. number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

Can Emergency Physicians Safely Exclude Proximal Deep Vein Thrombosis Using Limited Compression Emergency Department Ultrasound?

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Nov 3, 2009
Registry last updated
Jun 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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