Adjust-Unlikely PE

NCT05708794 | Completed

• 1 other identifier: 4269
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.Determine study recruitment rate, per site, per month
2. 2.Determine study 90-day loss to follow up rate
3. 3.Estimate of the proportion of enrolled patients who test negative for PE at initial assessment using the Adjust-Unlikely rule
4. 4.Estimate of the Adjust-Unlikely algorithm efficiency
5. 5.Compare excluded and missed-eligible patients to study participants: age, sex and prevalence of PE diagnoses at initial testing.

Conditions

Pulmonary Embolism (Diagnosis)

Keywords

emergency medicine; standardization of practice; diagnostics evaluation

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to emergency departments and urgent care centres with symptoms of PE.

You may qualify if:

• Emergency physician decides to test for PE

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Kerstin de Wit: lead
• Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network: collaborator

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Pulmonary Embolism; Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kerstin de Wit

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Kerstin de Wit, Associate Professor, Department of Emergency Medicine, Queen's University

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: April 23, 2023
• Primary Completion: September 8, 2023
• Study Completion: December 22, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)