Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study

Completed

• Conditions: Tuberculosis; Bronchiectasis; Acute Bronchitis; Chronic Obstructive Pulmonary Disease; Lung Cancer; Pneumonia; Cryptogenic Haemoptysis
• Interventions: Other: Chest X-ray; Other: computed tomography of the chest; Procedure: Bronchoscopy

• Registration Number: NCT02045394
• Lead Sponsor: University of Milan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Primary Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 610

Inclusion Criteria

• haemoptysis requiring a diagnosis

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients presenting with haemoptysis	computed tomography of the chest	-
Patients presenting with haemoptysis	Chest X-ray	-
Patients presenting with haemoptysis	Bronchoscopy	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients presenting with haemoptysis affected by lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis or other causes.	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).

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of chest X-ray, chest CT scan and bronchoscopy alone and in combination in the diagnosis of different causes of haemoptysis.	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).
Percentage and severity of recurrence of haemoptysis in the follow-up period.	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.
Patient survival in the follow-up period.	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.
Sensitivity and specificity of bronchoscopy in localizing the bleeding side and lobe in relation to the timing of the haemoptysis.	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).

Trial Locations

Locations (6)

A.O.U. Maggiore della Carità - S.C.D.O. Pneumologia; 🇮🇹 Novara, Italy

Clinica Pneumotisiologica, AOU Sassari; 🇮🇹 Sassari, Italy

Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano.; 🇮🇹 Milan, Italy

Pneumologia, Azienda Ospedaliero Universitaria; 🇮🇹 Ancona, Italy

USC Pneumologia, Azienda Ospedaliera della Provincia di Lodi; 🇮🇹 Lodi, Italy

U.O. di Pnuemologia, Azienda Ospedaliera, Carlo Poma; 🇮🇹 Mantova, Italy