NCT06320236

Emergency Medicine Pulmonary Embolism Testing Multicentre Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Dr. Kerstin de Wit · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Embolism
• D-dimer
• Diagnosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-09-30
• Completion: 2027-09-30
• First posted: 2024-03-20
• Last updated: 2026-04-14

Locations

1 site across 1 country: Canada