Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)

NCT06067997 | Completed

• 1 other identifier: CEACV 20160118
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemoptysis; Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• incidence of pulmonary embolism

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

  30 days within initial evaluation

Interventions

pulmonary embolism diagnosis DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Consecutive patients who present to the Emergency Department of the participating centers with hemoptysis
• consent to participate.

You may not qualify if:

• Pregnancy.
• Age below 18 years.
• Terminal illnesses with an estimated prognosis of less than 3 months.

Sponsors & Collaborators

• Società Italiana di Medicina di Emergenza-Urgenza: lead

Study Sites (1)

AOU Careggi

Florence, Tuscany, Italy

Location

Related 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.

  PMID: 9266882 RESULT

• 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.

  PMID: 28160237 RESULT

• 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.

  PMID: 24808437 RESULT

MeSH Terms

Conditions

Hemoptysis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Simone Vanni, Professor

  University of Florence

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 5, 2023
• Study Start: December 1, 2019
• Primary Completion: April 30, 2023
• Study Completion: August 30, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)