Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study

NCT02045394 | Completed

• 1 other identifier: HAEMOPTYSIS76
• Study Type: observational
• Target: 610
• Locations: 1 country
• Sites: 6

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.

Conditions

Lung Cancer; Tuberculosis; Bronchiectasis; Pneumonia; Acute Bronchitis; Chronic Obstructive Pulmonary Disease; Cryptogenic Haemoptysis

Keywords

haemoptysis; hemoptysis; airway bleeding

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• Percentage and severity of recurrence of haemoptysis in the follow-up period.

  18 months

• Sensitivity and specificity of bronchoscopy in localizing the bleeding side and lobe in relation to the timing of the haemoptysis.

  18 months

• Patient survival in the follow-up period.

  18 months

Other Outcomes (2)

• Prevalence of chronic obstructive pulmonary disease (COPD) in patients with haemoptysis by using spirometry with the threshold of FEV1/FVC <70

  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.

  18 months

Study Arms (1)

Patients presenting with haemoptysis

Other: Chest X-ray; Other: computed tomography of the chest; Procedure: Bronchoscopy

Interventions

Chest X-ray OTHER

Patients presenting with haemoptysis

computed tomography of the chest OTHER

Also known as: chest CT scan

Patients presenting with haemoptysis

Bronchoscopy PROCEDURE

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.

Patients presenting with haemoptysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inpatients and outpatients with haemoptysis requiring a diagnosis referred for medical consultation to italian university and clinical hospitals.

You may qualify if:

• haemoptysis requiring a diagnosis

You may not qualify if:

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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (6)

Pneumologia, Azienda Ospedaliero Universitaria

Ancona, Italy

Location

USC Pneumologia, Azienda Ospedaliera della Provincia di Lodi

Lodi, Italy

Location

U.O. di Pnuemologia, Azienda Ospedaliera, Carlo Poma

Mantova, Italy

Location

Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano.

Milan, 20142, Italy

Location

A.O.U. Maggiore della Carità - S.C.D.O. Pneumologia

Novara, Italy

Location

Clinica Pneumotisiologica, AOU Sassari

Sassari, Italy

Location

Related Publications (3)

• 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.

  PMID: 34348724 DERIVED

• 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.

  PMID: 30744616 DERIVED

• 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.

  PMID: 29301924 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Tuberculosis; Bronchiectasis; Pneumonia; Bronchitis; Pulmonary Disease, Chronic Obstructive; Hemoptysis

Interventions

X-Rays; Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bronchial Diseases; Respiratory Tract Infections; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Michele Mondoni, MD

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

  PRINCIPAL INVESTIGATOR

• Paolo Carlucci, MD

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

  STUDY CHAIR

• Stefano Centanni, MD, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 24, 2014
• Study Start: June 1, 2013
• Primary Completion: October 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

IT (6)