Health TrialsbyHealthPanel

Emergency Medicine Pulmonary Embolism Testing Multicentre Study

ConditionsPulmonary EmbolismD-dimerDiagnosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr. Kerstin de Wit

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

4,000 Participants
are divided into 1 treatment group
Group A: Emergency department patients tested for pulmonary embolism.1 intervention

Trial outcomes

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

Positive or negative 'Adjust-Unlikely' testing result

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Kerstin de Wit

Lead sponsor

Queen's University

Sponsor institution

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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