An observational study in Hemoptysis and Pulmonary Embolism, sponsored by Società Italiana di Medicina di Emergenza-Urgenza. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by Società Italiana di Medicina di Emergenza-Urgenza · Observational
Estimation of the incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis.
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.
37 studies on the registry are indexed under Hemoptysis; 6 are open to participants now.
This study's enrollment of 550 is above the median of 176 across 15 observational studies indexed under Hemoptysis.
Browse Hemoptysis studies →This is the only study on the registry with Società Italiana di Medicina di Emergenza-Urgenza as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
incidence of pulmonary embolism
The incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis/haemoptysis.
Time frame: 30 days within initial evaluation
Plan to share: No
Ran from Dec 2019 to primary completion in Apr 2023, 40 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.