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Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)

Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06067997
Acronym
POPEIHE
Enrollment
550
Registered
2023-10-05
Start date
2019-12-01
Completion date
2023-08-30
Last updated
2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemoptysis, Pulmonary Embolism

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.

Interventions

DIAGNOSTIC_TESTpulmonary 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.

Sponsors

Società Italiana di Medicina di Emergenza-Urgenza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
incidence of pulmonary embolism30 days within initial evaluationThe incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis/haemoptysis.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026