Emergency Medicine Pulmonary Embolism Testing Multicentre Study

NCT06320236 | Recruiting

• 1 other identifier: 4603
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

D-dimer; Pulmonary Embolism; Adjust-Unlikely; Diagnostic; Emergency Medicine

Outcome Measures

Primary Outcomes (1)

• Number of venous thrombosis events

  30 days

Secondary Outcomes (2)

• Number of venous thrombosis

  90 days

• Index presentation Adjust-Unlikely testing results

  90 days

Study Arms (1)

Emergency department patients tested for pulmonary embolism.

Diagnostic Test: Adjust-Unlikely

Interventions

Adjust-Unlikely DIAGNOSTIC_TEST

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.

Emergency department patients tested for pulmonary embolism.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Kerstin de Wit: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

Hamilton Health Sciences Corporation

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

London Health Sciences Centre Research Inc

London, Ontario, Canada

ACTIVE NOT RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism; Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kerstin de Wit, MD

  Queens University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha S Clayton

CONTACT

416-566-3590; natasha.clayton@queensu.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinician Investigator Program Director & Research Director for the Department of Emergency Medicine, Queen's University

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)