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OpenTrials
Completed

NCT Number: NCT06067997

Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)

Estimation of the incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis.

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Key information

About this study

Multicenter prospective observational cross-sectional study with non-commercial (non-profit) objectives.

The study population consists of consecutive patients who present to the Emergency Departments of the participating hospitals with hemoptysis.

The diagnosis of pulmonary embolism will be made using the diagnostic algorithm suggested by the 2019 European guidelines. The pre-test clinical probability of pulmonary embolism will be defined based on the simplified Wells score, which classifies pulmonary embolism as "likely" or "unlikely". In patients with a low pre-test clinical probability ("unlikely") and a D-dimer level below the threshold value (negative), the diagnosis of pulmonary embolism will be excluded, and further testing will not be necessary in this regard. The D-dimer level will be measured using the quantitative assay routinely used in each participating center; the threshold value for a positive result compared to a negative result is 500 μg per milliliter for patients under 50 years of age. For each additional decade of age, the exclusion cutoff will increase by 100 μg per milliliter.

For patients with a high pre-test clinical probability ("likely"), a positive D-dimer test, or both, a pulmonary CT angiography will be the diagnostic test of choice.

The criterion for the presence of pulmonary embolism is the detection of an intraluminal filling defect on CT.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Consecutive patients who present to the Emergency Department of the participating centers with hemoptysis
  • consent to participate.

Exclusion criteria

  • Pregnancy.
  • Age below 18 years.
  • Terminal illnesses with an estimated prognosis of less than 3 months.

Treatment and study plan

pulmonary embolism diagnosis

Diagnostic Test

The diagnosis of pulmonary embolism will be made using the diagnostic algorithm suggested by the 2019 European guidelines . The pre-test clinical probability of pulmonary embolism will be defined based on the simplified Wells score. In patients with a low pre-test clinical probability and a D-dimer level below the threshold value the diagnosis of pulmonary embolism will be excluded. The D-dimer level will be measured using the quantitative assay routinely used in each participating center; the threshold value for a positive result compared to a negative result is 500 μg per milliliter for patients under 50 years of age. For each additional decade of age, the exclusion cutoff will increase by 100 μg per milliliter.

The criterion for the presence of pulmonary embolism is the detection of an intraluminal filling defect on CT.

Primary outcomes

  1. incidence of pulmonary embolism

    Time frame: 30 days within initial evaluation

    The incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis/haemoptysis.

Sponsors and collaborators

Lead sponsor

Società Italiana di Medicina di Emergenza-Urgenza

Other

Registry information

Acronym: POPEIHE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2023
Registry last updated
Oct 5, 2023

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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