Emergency Medicine Pulmonary Embolism Testing Multicentre Study

NCT ID: NCT06320236

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2027-09-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Emergency department patients tested for pulmonary embolism.

Adjust-Unlikely

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Dr. Kerstin de Wit

OTHER

Sponsor Role: lead

Responsible Party

Dr. Kerstin de Wit

Clinician Investigator Program Director & Research Director for the Department of Emergency Medicine, Queen's University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kerstin de Wit, MD

Role: PRINCIPAL_INVESTIGATOR

Queens University

Locations

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Natasha S Clayton, CRA, RA

Role: CONTACT

natasha.clayton@queensu.ca

4165663590

Facility Contacts

Natasha Clayton, CRA, RA

Role: primary

natasha.clayton@queensu.ca

4165663590

Other Identifiers

4603

Identifier Type: -

Identifier Source: org_study_id