RecruitingNCT06320236

Emergency Medicine Pulmonary Embolism Testing Multicentre Study

Sponsor

Dr. Kerstin de Wit

Enrollment

4,000 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Diagnosis Pulmonary Embolism D-dimer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

Emergency department patient who is tested by an emergency physician for PE

Exclusion Criteria15

Patient is < 18 years of age
No documentation of whether PE is the most likely diagnosis
D-dimer is not tested or else not resulted during the emergency visit
The D-dimer level is known before documentation of whether PE is the most likely diagnosis
The D-dimer is ordered prior to the physician assessing the patient
The patient has previously registered that they opt out of all research at the participating site
The patient leaves against medical advice
The patient has had PE or deep vein thrombosis imaging (CT pulmonary angiogram, ventilation-perfusion scan or lower limb ultrasound) within prior 30 days
There is a new (non-PE) indication for anticoagulation
The patient was initiated on treatment for presumed PE prior to PE testing
The patient has previously been enrolled into the study
The patient has a prior history of lower extremity deep vein thrombosis without availability of a baseline ultrasound scan
The patient was transferred from another hospital organization
The patient does not reside in Ontario
The patient has no valid Ontario Health Insurance Plan card

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Interventions

DIAGNOSTIC_TESTAdjust-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.