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Recruiting NCT06320236

Emergency Medicine Pulmonary Embolism Testing Multicentre Study

Conditions: Pulmonary Embolism D-dimer Diagnosis

Sponsor: Dr. Kerstin de Wit

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * Emergency department patient who is tested by an emergency physician for PE Exclusion Criteria: * 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
Interventions
Adjust-Unlikely
DIAGNOSTIC_TEST
Locations 4
Canada (4)
Hamilton Health Sciences Corporation
Hamilton , Ontario
Kingston Health Sciences Centre
Kingston , Ontario
London Health Sciences Centre Research Inc
London , Ontario
ACTIVE_NOT_RECRUITING
Ottawa Hospital Research Institute
Ottawa , Ontario
ACTIVE_NOT_RECRUITING
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.01.2024
Completion date
30.09.2027
Registry ID
NCT06320236
Source
clinicaltrials.gov
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