Deep Vein Thrombosis Clinical Trial
Official title:
Age-Adjusted D-Dimer and Two-Site Compression POINt-OF-CARE Ultrasonography to Rule Out Acute Deep Vein Thrombosis
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.
n/a
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