Clinical trial NCT02045394: Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study
Official title: Multicenter, Prospective, Observational Study on Epidemiology and Diagnosis of Haemoptysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Tuberculosis
Bronchiectasis
Pneumonia
Acute Bronchitis
Chronic Obstructive Pulmonary Disease
Cryptogenic Haemoptysis
Keywords: haemoptysis
hemoptysis
airway bleeding
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients and outpatients with haemoptysis requiring a diagnosis referred for medical consultation to italian university and clinical hospitals.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* haemoptysis requiring a diagnosis

Exclusion Criteria:

* history of known bleeding lesions in the upper or lower airways

Primary outcomes:
measure: Percentage of patients presenting with haemoptysis affected by lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis or other causes.
timeFrame: 18 months
Secondary outcomes:
measure: Sensitivity and specificity of chest X-ray, chest CT scan and bronchoscopy alone and in combination in the diagnosis of different causes of haemoptysis.
timeFrame: 18 months
measure: Percentage and severity of recurrence of haemoptysis in the follow-up period.
timeFrame: 18 months
measure: Sensitivity and specificity of bronchoscopy in localizing the bleeding side and lobe in relation to the timing of the haemoptysis.
timeFrame: 18 months
measure: Patient survival in the follow-up period.
timeFrame: 18 months
Other outcomes:
measure: Prevalence of chronic obstructive pulmonary disease (COPD) in patients with haemoptysis by using spirometry with the threshold of FEV1/FVC <70
timeFrame: 1 month or at clinical stability
measure: Distribution of main causes of haemoptysis in the subgroup of patients undergoing medical therapies that increase the risk of bleeding.
timeFrame: 18 months
Locations:
city: Ancona
country: Italy
facility: Pneumologia, Azienda Ospedaliero Universitaria
city: Lodi
country: Italy
facility: USC Pneumologia, Azienda Ospedaliera della Provincia di Lodi
city: Mantova
country: Italy
facility: U.O. di Pnuemologia, Azienda Ospedaliera, Carlo Poma
city: Milan
country: Italy
facility: Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano.
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità - S.C.D.O. Pneumologia
city: Sassari
country: Italy
facility: Clinica Pneumotisiologica, AOU Sassari
Study officials:
affiliation: Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
name: Michele Mondoni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
name: Paolo Carlucci, MD
role: STUDY_CHAIR
affiliation: Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
name: Stefano Centanni, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.