HemoptysisPOPEIHENCT06067997
Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)
An observational study of Hemoptysis and Pulmonary Embolism, run by Società Italiana di Medicina di Emergenza-Urgenza at 1 site in Italy.
Trial summary
Estimation of the incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemoptysis, Pulmonary Embolism
- What is being tested?
- pulmonary embolism diagnosis
- How many people
- 550 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2019to 30 Aug 2023
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Consecutive patients who present to the Emergency Department of the participating centers with hemoptysis
- consent to participate.
Who cannot join
- Pregnancy.
- Age below 18 years.
- Terminal illnesses with an estimated prognosis of less than 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Estimation of the incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis.
Read the 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.
- Conditions
- Hemoptysis, Pulmonary Embolism
- Being tested
- pulmonary embolism diagnosis
- Medical subject headings
- Hemoptysis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary embolism diagnosisDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of pulmonary embolism
The incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis/haemoptysis.
Measured: 30 days within initial evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Dec 2019
- Primary completion30 Apr 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemoptysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Società Italiana di Medicina di Emergenza-Urgenza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Vanni, Professor, Study chair, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067997
- Sponsor's protocol ID
- CEACV 20160118
- Acronym
- POPEIHE
- Status last verified
- Oct 2023
- First submitted
- 12 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9266882Vanni 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.
PubMed 28160237Larici 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.
PubMed 24808437Pelagatti L, Bartalucci P, Fabiani G, Giannasi G, Ruggiano G, De Curtis E, di Maria V, Coppa A, Pepe G, Magazzini S, Voza A, Morello F, Nazerian P, Vanni S. Validation and implementation of the FLHASc score for risk stratification of patients with hemoptysis in the emergency department. Am J Emerg Med. 2026 Jun;104:154-161. doi: 10.1016/j.ajem.2026.03.020. Epub 2026 Mar 24.
PubMed 41905245
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Of Pulmonary Embolism In Patients With HEmoptysis (POPEIHE)
- ClinicalTrials.gov ID
- NCT06067997
- Acronym / sponsor ID
- POPEIHE / CEACV 20160118
- Conditions
- Hemoptysis, Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Società Italiana di Medicina di Emergenza-UrgenzaUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Consecutive patients who present to the Emergency Department of the participating centers with hemoptysis
- consent to participate.
Key exclusion criteria (3 listed)
- Pregnancy.
- Age below 18 years.
- Terminal illnesses with an estimated prognosis of less than 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary embolism diagnosisThe 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. | Diagnostic test | – |
Primary outcome
incidence of pulmonary embolism
Time frame: 30 days within initial evaluation
The incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis/haemoptysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Results publication: PubMed 9266882Hirshberg 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.
- Results publication: PubMed 28160237Vanni 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.
- Results publication: PubMed 24808437Larici 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.
- Derived from this study: PubMed 41905245Pelagatti L, Bartalucci P, Fabiani G, Giannasi G, Ruggiano G, De Curtis E, di Maria V, Coppa A, Pepe G, Magazzini S, Voza A, Morello F, Nazerian P, Vanni S. Validation and implementation of the FLHASc score for risk stratification of patients with hemoptysis in the emergency department. Am J Emerg Med. 2026 Jun;104:154-161. doi: 10.1016/j.ajem.2026.03.020. Epub 2026 Mar 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Vanni, Professor study chair
University of Florence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemoptysis and Pulmonary Embolism, run by Società Italiana di Medicina di Emergenza-Urgenza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of pulmonary embolism (time frame: 30 days within initial evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06067997, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.