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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06320236
Other study ID # 4603
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date September 30, 2027

Study information

Verified date March 2024
Source Queen's University
Contact Natasha S Clayton, CRA, RA
Phone 4165663590
Email natasha.clayton@queensu.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 positive results are 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. We have created a new tool (called Adjust-Unlikely) which could safely reduce pulmonary embolism imaging in Canada. Our 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. Our study aim is to prospectively validate Adjust-Unlikely pulmonary embolism testing in emergency patients with suspected pulmonary embolism.


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date September 30, 2027
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Kingston Health Sciences Centre Kingston Ontario

Sponsors (2)

Lead Sponsor Collaborator
Dr. Kerstin de Wit Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Venous thrombosis 30 days
Secondary Venous thrombosis 90 days
Secondary Index presentation Adjust-Unlikely testing results Positive or negative 'Adjust-Unlikely' testing result 90 days
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