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

NCT03056196 | Unknown

• 1 other identifier: 17-010
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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. 1.Negative follow-up phone questionnaire for patients who were sent home with no formal duplex venous scanning.
2. 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

Conditions

Deep Vein Thrombosis; Point of Care Ultrasound

Outcome Measures

Primary Outcomes (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.

  1 year

Interventions

point of care ultrasound DIAGNOSTIC_TEST

want to assess the ability of d-dimer test and point of care ultrasound to role out lower leg DVT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jewish General Hospital: lead

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior resident in emergency medicine

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 17, 2017
• Study Start: March 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: March 1, 2018
• Last Updated: February 17, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share