Actively Recruiting
Emergency Medicine Pulmonary Embolism Testing Multicentre Study
Led by Dr. Kerstin de Wit · Updated on 2026-04-20
4000
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
D
Dr. Kerstin de Wit
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new clinical decision tool called Adjust-Unlikely to improve the testing process for pulmonary embolism in emergency department patients suspected of having this condition. Pulmonary embolism diagnosis is critical to prevent death and long-term disability, but current imaging tests expose patients to radiation, are costly, time-consuming, and sometimes lead to false positives. This observational study aims to validate the Adjust-Unlikely rule, which has been developed with input from physicians and patients to reduce unnecessary imaging safely and effectively. The Adjust-Unlikely tool combines physician judgment with D-dimer blood test results and imaging scans when needed. It categorizes patients based on whether pulmonary embolism is considered the most likely diagnosis and uses age-adjusted D-dimer thresholds to decide if imaging is necessary. Local laboratory D-dimer assays will be used for testing. The study includes emergency department patients tested for pulmonary embolism and will observe their outcomes without assigning treatments. Participants will be monitored for 30 and 90 days to track venous thrombosis events and the accuracy of the Adjust-Unlikely testing at the time of their emergency visit. Data collection involves recording physician assessments, D-dimer test results, and any imaging done. The study will help determine if this decision rule can safely reduce unnecessary imaging and improve care during emergency visits. The study is expected to continue until September 2027.
CONDITIONS
Brief Title
Emergency Medicine Pulmonary Embolism Testing Multicentre Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Emergency department patient who is tested by an emergency physician for PE
- Age 18 years or older
You will not qualify if you...
- Patient is younger than 18 years
- No documentation of whether PE is the most likely diagnosis
- D-dimer is not tested or not resulted during the emergency visit
- D-dimer level is known before documentation of whether PE is the most likely diagnosis
- D-dimer ordered before physician assessment
- Patient opted out of all research at the site
- Patient leaves against medical advice
- PE or deep vein thrombosis imaging within prior 30 days
- New non-PE indication for anticoagulation
- Treatment for presumed PE started before testing
- Previously enrolled in the study
- Prior lower extremity deep vein thrombosis without baseline ultrasound
- Patient transferred from another hospital
- Patient does not reside in Ontario
- No valid Ontario Health Insurance Plan card
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single emergency department visit
Participants undergo diagnostic testing to assess for pulmonary embolism during emergency department assessment.
1 visit (in-person)
Duration - Up to 90 days
Participants are monitored for venous thrombosis events following the diagnostic evaluation.
Follow-up assessments may occur depending on clinical care
Trial Site Locations
Total: 4 locations
1
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
2
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
3
London Health Sciences Centre Research Inc
London, Ontario, Canada
Active, Not Recruiting
4
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 4E9
Active, Not Recruiting
Research Team
N
Natasha S Clayton
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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