Improving Emergency Department Testing for Deep Vein Thrombosis

NCT06195787 | Completed

• 1 other identifier: 3717
• Study Type: observational
• Target: 458
• Locations: 1 country
• Sites: 1

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. 1.How safe is our new blood clot testing method?
2. 2.How efficient is our new blood clot testing method?

Conditions

Deep Vein Thrombosis (DVT)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• False negative rate of the new DVT testing

  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.

  This will be measured at 30-days after the patient's index emergency department visit.

Secondary Outcomes (1)

• Efficiency of the new DVT testing

  At the index emergency department visit.

Eligibility Criteria

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

Study Population

Study participants will be enrolled after a visit to the Kingston Health Sciences emergency department and urgent care centre in Kingston, Ontario.

You may qualify if:

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

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Dr. Kerstin de Wit: lead
• Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network: collaborator

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L2V7, Canada

Location

MeSH Terms

Conditions

Venous Thrombosis; Venous Thromboembolism; Disease

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Department of Emergency Medicine

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 8, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)