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Clinical Trials/NCT05708794
NCT05708794
Completed
Not Applicable

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

Dr. Kerstin de Wit1 site in 1 country200 target enrollmentApril 23, 2023
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ConditionsPulmonary Embolism (Diagnosis)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Embolism (Diagnosis)
Sponsor
Dr. Kerstin de Wit
Enrollment
200
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 23, 2023
End Date
December 22, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Dr. Kerstin de Wit
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Kerstin de Wit

Dr. Kerstin de Wit, Associate Professor, Department of Emergency Medicine, Queen's University

Queen's University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: 90 days following index presentation

Study Sites (1)

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