Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)

Completed

• Conditions: Pulmonary Embolism; Hemoptysis

• Registration Number: NCT06067997
• Lead Sponsor: Società Italiana di Medicina di Emergenza-Urgenza

Brief 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.

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-08-30
• Study First Submitted: 2023-09-12
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-03
• Last Update Submitted: 2023-10-03
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of pulmonary embolism	30 days within initial evaluation	The incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis/haemoptysis.

Trial Locations

Locations (1)

AOU Careggi; 🇮🇹 Florence, Tuscany, Italy