Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study

Lung Cancer Clinical Trial

Official title:

Multicenter, Prospective, Observational Study on Epidemiology and Diagnosis of Haemoptysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045394
• Other study ID #: HAEMOPTYSIS76
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: December 2, 2015
• Start date: June 2013

Study information

• Verified date: December 2015
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• haemoptysis requiring a diagnosis

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Bronchitis
• Bronchiectasis
• Bronchitis
• Chronic Obstructive Pulmonary Disease
• Cryptogenic Haemoptysis
• Hemoptysis
• Lung Cancer
• Lung Diseases, Obstructive
• Pneumonia
• Pulmonary Disease, Chronic Obstructive
• Tuberculosis

Intervention

Other:
• Chest X-ray

• computed tomography of the chest

Procedure:
• Bronchoscopy
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.

Locations

Country	Name	City	State
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	Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano.	Milan
Italy	A.O.U. Maggiore della Carità - S.C.D.O. Pneumologia	Novara
Italy	Clinica Pneumotisiologica, AOU Sassari	Sassari

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of chronic obstructive pulmonary disease (COPD) in patients with haemoptysis by using spirometry with the threshold of FEV1/FVC <70	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.	1 month or at clinical stability	No
Other	Distribution of main causes of haemoptysis in the subgroup of patients undergoing medical therapies that increase the risk of bleeding.	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	No
Primary	Percentage of patients presenting with haemoptysis affected by lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis or other causes.	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	No
Secondary	Sensitivity and specificity of chest X-ray, chest CT scan and bronchoscopy alone and in combination in the diagnosis of different causes of haemoptysis.	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	No
Secondary	Percentage and severity of recurrence of haemoptysis in the follow-up period.	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	No
Secondary	Sensitivity and specificity of bronchoscopy in localizing the bleeding side and lobe in relation to the timing of the haemoptysis.	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	No
Secondary	Patient survival in the follow-up period.	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	No