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Two-Site Compression POINt-OF-CARE Ultrasonography for DVT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056196
Recruitment Status : Unknown
Verified February 2017 by Khalifa Alqaydi, Jewish General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Khalifa Alqaydi, Jewish General Hospital

Brief Summary:

Introduction

Undiagnosed deep vein thrombosis (DVT) can lead to significant morbidity and mortality, including death from DVT-associated massive pulmonary embolism (PE). While several validated clinical prediction rules, blood test and imaging modalities exist to investigate a potential DVT, there is currently a lack of rapid, accessible and reliable methods to exclude the possibility of DVT without resorting to formal venous duplex scanning.

Currently, the use in the ED of a validated clinical prediction rule combined with high-sensitivity D-dimer test has a poor predictive value, as 75-90% of patients suspected of DVT have a negative formal venous duplex scan.

Compression bedside ultrasound has however recently been shown to be a safe, rapid and accurate method for the diagnosis of proximal DVT in the emergency department with a high sensitivity and specificity (combined sensitivity and specificity of 96.1% and 96.8%, respectively1).

Research Question

In the present study, the investigators will primarily assess whether two-site compression POCUS combined with a negative age-adjusted D-dimer test can accurately rule out DVT in ED patients regardless of the Wells criteria.

Methods

This is a single-center, prospective, observational study carried out over one year in the Emergency Department of the Jewish General Hospital in Montreal, Quebec. The investigators aim to enroll a convenience sample of 475 patients aged 18 years and older presenting to the ED with symptoms suggestive of a DVT. All enrolled patients will receive the standard of care required for a lower leg DVT presentation. After calculating Patients DVT risk using modified wells criteria, all patients will undergo POCUS for DVT followed by a D-dimer test. Based on their results, patients will either undergo formal duplex scanning, or will be discharged without further testing and receive a three-month phone follow-up.

A true negative lower leg DVT will be defined as follows:

  1. Negative follow-up phone questionnaire for patients who were sent home with no formal duplex venous scanning.
  2. Negative formal duplex venous scanning for patients who were deemed likely to have lower leg DVT using the Wells score, with a negative D-dimer and POCUS

Age-adjusted DVT was added to account for below knee DVT and avoid the need for patients to return for fellow up duplex study in 1 week.

To estimate our technique's sensitivity with a 4% margin of error with 95% confidence intervals, 92 confirmed DVT patients are needed. The investigators expect to recruit a total 475 patients within one-year period at the JGH (95 DVT-positive patients and 380 DVT-negative patients).

Impact

The use of compression bedside ultrasound with a negative age-adjusted D-dimer test to rule out DVT in the ED may accelerate the decision regarding patient disposition and significantly decrease the length of patient stay in the ED. In addition, it may help avoid unnecessary medical interventions and diagnostic tests, thus representing potential quality of care and cost-saving improvements as well.


Condition or disease Intervention/treatment
Deep Vein Thrombosis Point of Care Ultrasound Diagnostic Test: point of care ultrasound

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Age-Adjusted D-Dimer and Two-Site Compression POINt-OF-CARE Ultrasonography to Rule Out Acute Deep Vein Thrombosis
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: point of care ultrasound
    want to assess the ability of d-dimer test and point of care ultrasound to role out lower leg DVT


Primary Outcome Measures :
  1. Number of Participants who can have the diagnosis of DVT excluded using two-site compression POCUS combined with a negative age-adjusted D-dimer regardless of the Wells criteria. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients aged 18 years and older presenting to the ED with symptoms suggestive of a DVT
Criteria

Inclusion Criteria:

  • patients aged 18 years and older presenting to the ED with symptoms suggestive of a DVT

Exclusion Criteria:

  • Pregnancy
  • Recent traumatic injury to the lower extremity
  • Hemodynamic instability
  • Suspected pulmonary embolism
  • CT angiography (pulmonary embolism protocol including lower extremities) performed before ED POCUS
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Responsible Party: Khalifa Alqaydi, senior resident in emergency medicine, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT03056196    
Other Study ID Numbers: 17-010
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not going to share patients data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases