Adjust-Unlikely PE
- Conditions
- Pulmonary Embolism (Diagnosis)
- Registration Number
- NCT05708794
- Lead Sponsor
- Dr. Kerstin de Wit
- Brief Summary
The aim of this pilot study is to assess the feasibility of a larger study to determine the Adjust-Unlikely algorithm safety and efficiency for diagnosing PE.
The pilot study objectives are to:
1. Determine study recruitment rate, per site, per month
2. Determine study 90-day loss to follow up rate
3. Estimate of the proportion of enrolled patients who test negative for PE at initial assessment using the Adjust-Unlikely rule
4. Estimate of the Adjust-Unlikely algorithm efficiency
5. Compare excluded and missed-eligible patients to study participants: age, sex and prevalence of PE diagnoses at initial testing.
The pilot study hypothesis is that the investigators can recruit at least 20 patients per month and successfully follow at least 90% of patients for 90 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Emergency physician decides to test for PE
- Tested for PE without using the Adjust-Unlikely algorithm
- D-dimer level is known before Adjust-Unlikely assessment
- A new indication for anticoagulation on emergency department assessment (other than pulmonary embolism) in a patient not previously prescribed an anticoagulant
- Declines participation
- Is inaccessible for follow-up
- Has previously participated in this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients who have PE excluded by the Adjust-Unlikely algorithm and who are subsequently diagnosed with either PE or lower limb DVT. 90 days following index presentation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada