- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02045394
Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study
December 2, 2015 updated by: Fabiano Di Marco, University of Milan
Multicenter, Prospective, Observational Study on Epidemiology and Diagnosis of Haemoptysis
Haemoptysis is the coughing up of blood originating from the respiratory tract.
It is a common and worrying clinical symptom which can be due to different aetiologies including lung cancer, tuberculosis, COPD, bronchiectasis, pneumonia, acute bronchitis or unknown origin (cryptogenic haemoptysis).
Epidemiology and optimal diagnostic approach are largely unclear.
Aims of this study are to define current epidemiology and to provide the best diagnostic approach by providing a diagnostic algorithm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
610
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ancona, Italy
- Pneumologia, Azienda Ospedaliero Universitaria
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Lodi, Italy
- USC Pneumologia, Azienda Ospedaliera della Provincia di Lodi
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Mantova, Italy
- U.O. di Pnuemologia, Azienda Ospedaliera, Carlo Poma
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Milan, Italy, 20142
- Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano.
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Novara, Italy
- A.O.U. Maggiore della Carità - S.C.D.O. Pneumologia
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Sassari, Italy
- Clinica Pneumotisiologica, AOU Sassari
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Inpatients and outpatients with haemoptysis requiring a diagnosis referred for medical consultation to italian university and clinical hospitals.
Description
Inclusion Criteria:
- haemoptysis requiring a diagnosis
Exclusion Criteria:
- history of known bleeding lesions in the upper or lower airways
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients presenting with haemoptysis
|
Other Names:
In patients with haemoptysis bronchoscopy will be performed with flexible bronchoscope.
A systemic research of bleeding site and causes will be done.
Microbiological or pathological sampling will be executed if clinically required.
In selected patients, bronchoscopy might be performed with the rigid instrument or the flexible bronchoscope in intubated patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients presenting with haemoptysis affected by lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis or other causes.
Time Frame: 18 months
|
To define the prevalence of diseases presenting with haemoptysis by measuring percentage of patients presenting with haemoptysis affected by lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis or other causes.
Epidemiology will be analysed related to the severity of the symptom (mild haemoptysis: drops of blood or bloody sputum; moderate haemoptysis: <500 ml/24 h, severe haemoptysis: 1-2 cups, as defined by Hirshberg et al.
CHEST 1997).
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity of chest X-ray, chest CT scan and bronchoscopy alone and in combination in the diagnosis of different causes of haemoptysis.
Time Frame: 18 months
|
Sensitivity, specificity, positive and negative predictive values of of chest X-ray, computed tomography (CT) scan and bronchoscopy executed alone versus the combination of the exams in the diagnosis of different causes of haemoptysis (lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis and other causes).
|
18 months
|
Percentage and severity of recurrence of haemoptysis in the follow-up period.
Time Frame: 18 months
|
Every patient will be followed with scheduled visits and phone calls for 18 months since the first episode of haemoptysis.
The percentage of patient with recurrence of haemoptysis, the severity of recurrence, will be measured and analysed by descriptive statistics.
|
18 months
|
Sensitivity and specificity of bronchoscopy in localizing the bleeding side and lobe in relation to the timing of the haemoptysis.
Time Frame: 18 months
|
Accuracy of bronchoscopy in localizing the side and the lobe source of the bleeding in relation to the timing of haemoptysis.
The bronchoscopic findings will be analysed in relation to the timing of the bleeding (within 24 hours, between 24 and 48, 49 and 96 or over 96 hours after the occurrence of the symptom).
|
18 months
|
Patient survival in the follow-up period.
Time Frame: 18 months
|
Every patient will be followed with scheduled visits and phone calls for 18 months since the first episode of haemoptysis.
Patient survival will be measured and analysed by descriptive statistics.
|
18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of chronic obstructive pulmonary disease (COPD) in patients with haemoptysis by using spirometry with the threshold of FEV1/FVC <70
Time Frame: 1 month or at clinical stability
|
Prevalence of chronic obstructive pulmonary disease (COPD) in patients with haemoptysis will be assessed performing spirometry as described by European Respiratory Society Guidelines (European Respiratory Journal, 2005).
COPD will be diagnosed in patient with a compatible clinical history (smoking history and frequent exacerbations) and the presence of a ventilatory obstructive defect as defined by a ratio of the forced expiratory volume in the first second and forced vital capacity (FEV1/FVC) <70.
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1 month or at clinical stability
|
Distribution of main causes of haemoptysis in the subgroup of patients undergoing medical therapies that increase the risk of bleeding.
Time Frame: 18 months
|
To define the prevalence of diseases in patients presenting with haemoptysis in relation to the use of drugs such as antiaggregants or anticoagulants.
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michele Mondoni, MD, Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
- Study Chair: Paolo Carlucci, MD, Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
- Study Director: Stefano Centanni, MD, PhD, Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mondoni M, Carlucci P, Cipolla G, Pagani M, Tursi F, Fois A, Pirina P, Canu S, Gasparini S, Bonifazi M, Marani S, Comel A, Saderi L, De Pascalis S, Alfano F, Centanni S, Sotgiu G. Long-term prognostic outcomes in patients with haemoptysis. Respir Res. 2021 Aug 4;22(1):219. doi: 10.1186/s12931-021-01809-6.
- Mondoni M, Carlucci P, Cipolla G, Fois A, Gasparini S, Marani S, Centanni S, Sotgiu G. Bronchoscopy to assess patients with hemoptysis: which is the optimal timing? BMC Pulm Med. 2019 Feb 11;19(1):36. doi: 10.1186/s12890-019-0795-9.
- Mondoni M, Carlucci P, Job S, Parazzini EM, Cipolla G, Pagani M, Tursi F, Negri L, Fois A, Canu S, Arcadu A, Pirina P, Bonifazi M, Gasparini S, Marani S, Comel AC, Ravenna F, Dore S, Alfano F, Sferrazza Papa GF, Di Marco F, Centanni S, Sotgiu G. Observational, multicentre study on the epidemiology of haemoptysis. Eur Respir J. 2018 Jan 4;51(1):1701813. doi: 10.1183/13993003.01813-2017. Print 2018 Jan. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (ACTUAL)
October 1, 2015
Study Registration Dates
First Submitted
January 13, 2014
First Submitted That Met QC Criteria
January 22, 2014
First Posted (ESTIMATE)
January 24, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
December 3, 2015
Last Update Submitted That Met QC Criteria
December 2, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Hemorrhage
- Bronchial Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Signs and Symptoms, Respiratory
- Mycobacterium Infections
- Bronchiectasis
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Tuberculosis
- Bronchitis
- Hemoptysis
Other Study ID Numbers
- HAEMOPTYSIS76
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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