Improving Emergency Department Testing for Deep Vein Thrombosis

Deep Vein Thrombosis (DVT) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06195787
• Other study ID #: 3717
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Queen's University
• Contact: Natasha Clayton
• Phone: 4165663590
• Email: nc96[@]queensu.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 DAYS algorithm at the index visit;
• D-dimer level is known before DAYS 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.

Related Conditions & MeSH terms

• Deep Vein Thrombosis (DVT)
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Kerstin de Wit	Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	False negative rate of the new DVT testing	This is the proportion of patients who have DVT excluded by the new DAYS 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	Efficiency of the new DVT testing	This is the proportion of all study patients who do not require ultrasound imaging at index visit.	At the index emergency department visit.