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Adjust-Unlikely PE

A Pilot Study to Assess Feasibility of Evaluating the Safety and Efficiency of a Simplified Diagnostic Approach for Pulmonary Embolism

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05708794
Enrollment
200
Registered
2023-02-01
Start date
2023-04-23
Completion date
2023-12-22
Last updated
2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism (Diagnosis)

Keywords

emergency medicine, standardization of practice, diagnostics evaluation

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.

Interventions

None listed

Sponsors

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
CollaboratorNETWORK
Dr. Kerstin de Wit
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Emergency physician decides to test for PE

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026