Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)

• Sponsor: Società Italiana di Medicina di Emergenza-Urgenza (Other)
• Overall Status: Completed
• CT.gov ID: NCT06067997
• Collaborator: (none)
• Enrollment: 550
• Location: 1
• Actual Duration (Months): 44.9
• Patients Per Site Per Month: 12.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hemoptysis; Pulmonary Embolism	Diagnostic Test: pulmonary embolism diagnosis

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 550 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)
• Actual Study Start Date: Dec 1, 2019
• Actual Primary Completion Date: Apr 30, 2023
• Actual Study Completion Date: Aug 30, 2023

Outcome Measures

Primary Outcome Measures

1. incidence of pulmonary embolism [30 days within initial evaluation]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Careggi	Florence	Tuscany	Italy

Sponsors and Collaborators

• Società Italiana di Medicina di Emergenza-Urgenza

Investigators

• Study Chair: Simone Vanni, Professor, University of Florence

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Società Italiana di Medicina di Emergenza-Urgenza
• ClinicalTrials.gov Identifier: NCT06067997
• Other Study ID Numbers: CEACV 20160118
• First Posted: Oct 5, 2023
• Last Update Posted: Oct 5, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Embolism; Hemoptysis; Embolism

Study Results

No Results Posted as of Oct 5, 2023