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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06067997
Other study ID # CEACV 20160118
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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