Improving Emergency Department Testing for Deep Vein Thrombosis

Assessing the Safety and Efficiency of a Simplified Diagnostic Approach for Deep Vein Thrombosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06195787

Enrollment

458

Registered

2024-01-08

Start date

2024-01-01

Completion date

2025-01-01

Last updated

2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis (DVT)

Keywords

deep vein thrombosis, venous thromboembolism, emergency medical services, diagnosis

Brief summary

This observational study will use a new way to test for deep vein thrombosis (DVT) of the leg. A DVT is a blood clot in the leg and is a medical problem that can cause swelling, pain, and redness. If the blood clot is not treated, it can cause more serious, long-term effects, and occasionally lead to death. The main questions the study aims to answer are: 1. How safe is our new blood clot testing method? 2. How efficient is our new blood clot testing method? The study will be run in the emergency department and urgent care centre in Kingston, Ontario. Patients who are tested for a DVT in the leg can be included in the study. Researchers follow the patient through chart review to make sure the new system is safe and efficient.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

\- emergency physician decides to test for DVT of the lower limb.

Exclusion criteria

* \<18 years of age; * tested for DVT without using the ToDay algorithm at the index visit; * D-dimer level is known before ToDay item assessment; * a new indication for anticoagulation at the emergency department assessment (other than DVT) in a patient not previously prescribed an anticoagulant; * a history of prior lower limb DVT, where there is no access to baseline ultrasound imaging; * suspected of having a pulmonary embolism; * has previously participated in this study; * has previously opted out of all research at hospital site; * left the emergency department or urgent care centre against medical advice; * D-dimer was ordered prior to initial physician assessment; * imaging for DVT or pulmonary embolism within the previous 30 days; * transferred from another hospital organization.

Design outcomes

Primary

Measure	Time frame	Description
False negative rate of the new DVT testing	This will be measured at 30-days after the patient's index emergency department visit.	This is the proportion of patients who have DVT excluded by the new ToDay protocol and who were subsequently diagnosed with either a lower limb DVT or pulmonary embolism.

Secondary

Measure	Time frame	Description
Efficiency of the new DVT testing	At the index emergency department visit.	This is the proportion of all study patients who do not require ultrasound imaging at index visit.

Countries

Canada

Outcome results