Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06067997
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2023-09-12
Brief Title:
Prevalence Of Pulmonary Embolism In Patients With HEmoptysis POPEIHE
Sponsor:
Società Italiana di Medicina di Emergenza-Urgenza
Organization:
Società Italiana di Medicina di Emergenza-Urgenza
Study Overview
Official Title:
Prevalence Of Pulmonary Embolism In Patients With HEmoptysis POPEIHE
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POPEIHE
Brief Summary:
Estimation of the incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None