Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)
NCT ID: NCT06067997
Last Updated: 2023-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
550 participants
OBSERVATIONAL
2019-12-01
2023-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* consent to participate.
Exclusion Criteria
* Age below 18 years.
* Terminal illnesses with an estimated prognosis of less than 3 months.
18 Years
ALL
No
Sponsors
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Società Italiana di Medicina di Emergenza-Urgenza
OTHER
Responsible Party
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Principal Investigators
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Simone Vanni, Professor
Role: STUDY_CHAIR
University of Florence
Locations
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AOU Careggi
Florence, Tuscany, Italy
Countries
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References
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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.
Other Identifiers
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CEACV 20160118
Identifier Type: -
Identifier Source: org_study_id
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