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RECRUITING
NCT06320236

Emergency Medicine Pulmonary Embolism Testing Multicentre Study

Sponsor: Dr. Kerstin de Wit

View on ClinicalTrials.gov

Summary

It is important to diagnose pulmonary embolism in a timely manner to prevent death and long-term disability. More than half a million people (4-5% of emergency department patients) are tested for pulmonary embolism, although the positive rate is low. Imaging for PE testing exposes patients to radiation, is expensive, adds time to the emergency visit, and can lead to a false positive diagnoses. Existing protocols aimed at reducing unnecessary pulmonary embolism imaging are complex and seldom used by emergency physicians. Too many patients undergo unnecessary pulmonary embolism imaging. A new tool (called Adjust-Unlikely) could safely reduce pulmonary embolism imaging in Canada. A research group composed of researchers, emergency physicians, and patients developed the Adjust-Unlikely clinical decision rule: a rule which has been customized for emergency physicians and emergency patients. Adjust-Unlikely is highly sensitive at the bedside, meaning there are very few false negative results. The study aim is to prospectively validate Adjust-Unlikely pulmonary embolism testing in emergency patients with suspected pulmonary embolism.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

4000

Start Date

2024-01-01

Completion Date

2027-09-30

Last Updated

2024-10-30

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Adjust-Unlikely

Pulmonary embolism will be excluded during emergency department assessment by the combination of: 1. 'Pulmonary embolism is the most likely diagnosis' as per the treating physician AND a D-dimer result \< 500 ug/L fibrinogen equivalent units; 2. 'Pulmonary embolism is not the most likely diagnosis' AND D-dimer \< age-adjusted threshold; or, 3. A negative computed tomography scan, planar ventilation perfusion scan or ventilation perfusion-SPECT. Emergency departments will use their local laboratory D-dimer assay.

Locations (1)

Kingston Health Sciences Centre

Kingston, Ontario, Canada