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NCT Number: NCT06320236

Emergency Medicine Pulmonary Embolism Testing Multicentre Study

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton Health Sciences Corporation, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adjust-Unlikely

Diagnostic Test

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.

Primary outcomes

  1. Number of venous thrombosis events

    Time frame: 30 days

Secondary outcomes

  1. Number of venous thrombosis

    Time frame: 90 days

  2. Index presentation Adjust-Unlikely testing results

    Time frame: 90 days

    Positive or negative 'Adjust-Unlikely' testing result

Study contacts

Contact information is provided by the study sponsor or research team.

Natasha S Clayton

CONTACT

[email protected]

416-566-3590

Sponsors and collaborators

Lead sponsor

Dr. Kerstin de Wit

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: EMPET

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 20, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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