Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)

Pulmonary Embolism Clinical Trial

— POPEIHE  

Official title:

Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06067997
• Other study ID #: CEACV 20160118
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2023
• Source: Società Italiana di Medicina di Emergenza-Urgenza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: August 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Hemoptysis
• Pulmonary Embolism

Intervention

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.

Locations

Country	Name	City	State
Italy	AOU Careggi	Florence	Tuscany

Sponsors (1)

Lead Sponsor	Collaborator
Società Italiana di Medicina di Emergenza-Urgenza

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of pulmonary embolism	The incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis/haemoptysis.	30 days within initial evaluation