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Completed

NCT Number: NCT05708794

Adjust-Unlikely PE

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.

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Key information

Conditions

Pulmonary Embolism (Diagnosis) Cardiovascular Diseases Disease Embolism Embolism and Thrombosis Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    Time frame: 90 days following index presentation

Sponsors and collaborators

Lead sponsor

Dr. Kerstin de Wit

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2023
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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