NCT06067997

Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 550 (actual)
• Sponsor: Società Italiana di Medicina di Emergenza-Urgenza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Hemoptysis
• Pulmonary Embolism

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	pulmonary embolism diagnosis	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.

Timeline

• Start date: 2019-12-01
• Primary completion: 2023-04-30
• Completion: 2023-08-30
• First posted: 2023-10-05
• Last updated: 2023-10-05

Locations

1 site across 1 country: Italy