Improving Emergency Department Testing for Deep Vein Thrombosis

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.

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Key information

Conditions

Deep Vein Thrombosis (DVT) Cardiovascular Diseases Disease Embolism and Thrombosis Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kingston Health Sciences Centre

Kingston, Ontario, K7L2V7, Canada

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

False negative rate of the new DVT testing

Time frame: 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 outcomes

Efficiency of the new DVT testing

Time frame: At the index emergency department visit.

This is the proportion of all study patients who do not require ultrasound imaging at index visit.

Sponsors and collaborators

Lead sponsor

Dr. Kerstin de Wit

Other

Collaborators

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Jan 8, 2024
Registry last updated: May 15, 2025

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.

Published trials that share one or more normalized conditions with this study.

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