Adjust-Unlikely PE

NCT ID: NCT05708794

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-23

Study Completion Date

2023-12-22

Brief Summary

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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

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Conditions

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Pulmonary Embolism (Diagnosis)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

NETWORK

Sponsor Role collaborator

Dr. Kerstin de Wit

OTHER

Sponsor Role lead

Responsible Party

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Dr. Kerstin de Wit

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

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kerstin de Wit

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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4269

Identifier Type: -

Identifier Source: org_study_id

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