Improving Emergency Department Testing for Deep Vein Thrombosis

Assessing the Safety and Efficiency of a Simplified Diagnostic Approach 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.

Study Overview

• Status: Recruiting
• Conditions: Deep Vein Thrombosis (DVT)

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Natasha Clayton; Phone Number: 4165663590; Email: nc96@queensu.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L2V7
      • Recruiting
      • Kingston Health Sciences Centre
      • Contact: Kerstin de Wit; Email: kerstin.dewit@queensu.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: diagnosis; venous thromboembolism; deep vein thrombosis; emergency medical services
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: 3717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No