Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE) (POPEIHE)

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism; Hemoptysis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 550

Contacts and Locations

Study Locations

• Italy
  • Tuscany
    • Florence, Tuscany, Italy
      • AOU Careggi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of consecutive patients who present to the Emergency Department of the participating hospitals with hemoptysis and agree to participate in the study. Patients under 18 years of age, pregnant patients, and patients with terminal illnesses with an estimated prognosis of less than 3 months will be excluded from the study. Data will be collected prospectively. The 30-day follow-up will be conducted by reviewing hospital documentation, any scheduled outpatient visits, any readmissions to the Emergency Department within the first 30 days in all Emergency Departments of the region, and, if necessary, through telephone follow-up.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of pulmonary embolism	The incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis/haemoptysis.	30 days within initial evaluation

Collaborators and Investigators

• Sponsor: Società Italiana di Medicina di Emergenza-Urgenza
• Investigators: Study Chair: Simone Vanni, Professor, University of Florence

Publications and helpful links

General Publications

• Hirshberg B, Biran I, Glazer M, Kramer MR. Hemoptysis: etiology, evaluation, and outcome in a tertiary referral hospital. Chest. 1997 Aug;112(2):440-4. doi: 10.1378/chest.112.2.440.
• Vanni S, Bianchi S, Bigiarini S, Casula C, Brogi M, Orsi S, Acquafresca M, Corbetta L, Grifoni S. Management of patients presenting with haemoptysis to a Tertiary Care Italian Emergency Department: the Florence Haemoptysis Score (FLHASc). Intern Emerg Med. 2018 Apr;13(3):397-404. doi: 10.1007/s11739-017-1618-8. Epub 2017 Feb 3.
• Larici AR, Franchi P, Occhipinti M, Contegiacomo A, del Ciello A, Calandriello L, Storto ML, Marano R, Bonomo L. Diagnosis and management of hemoptysis. Diagn Interv Radiol. 2014 Jul-Aug;20(4):299-309. doi: 10.5152/dir.2014.13426.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hemorrhage; Embolism and Thrombosis; Signs and Symptoms, Respiratory; Embolism; Pulmonary Embolism; Hemoptysis
• Other Study ID Numbers: CEACV 20160118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No