Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Milan
Sponsor:
Information provided by (Responsible Party):
Fabiano Di Marco, University of Milan
ClinicalTrials.gov Identifier:
NCT02045394
First received: January 13, 2014
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


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

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Multicenter, Prospective, Observational Study on Epidemiology and Diagnosis of Haemoptysis

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • Percentage of patients presenting with haemoptysis affected by lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis or other causes. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.

  • Sensitivity and specificity of bronchoscopy in localizing the bleeding side and lobe in relation to the timing of the haemoptysis. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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).

  • Patient survival in the follow-up period. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Distribution of main causes of haemoptysis in the subgroup of patients undergoing medical therapies that increase the risk of bleeding. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To define the prevalence of diseases in patients presenting with haemoptysis in relation to the use of drugs such as antiaggregants or anticoagulants.


Estimated Enrollment: 190
Study Start Date: June 2013
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients presenting with haemoptysis Other: Chest X-ray Other: computed tomography of the chest
Other Name: chest CT scan
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • haemoptysis requiring a diagnosis

Exclusion Criteria:

  • history of known bleeding lesions in the upper or lower airways
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02045394

Contacts
Contact: Michele Mondoni, M.D. +39.02.81843025 ext 3023 michele.mondoni@ao-sanpaolo.it

Locations
Italy
Pneumologia, Azienda Ospedaliero Universitaria Recruiting
Ancona, Italy
Contact: Martina Bonifazi, MD       martinabonifazi@libero.it   
Principal Investigator: Stefano Gasparini, MD         
Sub-Investigator: Martina Bonifazi, MD         
USC Pneumologia, Azienda Ospedaliera della Provincia di Lodi Recruiting
Lodi, Italy
Contact: Giuseppe Cipolla, MD       giucip@alice.it   
Principal Investigator: Giuseppe Cipolla, MD         
U.O. di Pnuemologia, Azienda Ospedaliera, Carlo Poma Recruiting
Mantova, Italy
Contact: Andrea Claudio Comel, MD       andreaclaudiocomel@gmail.com   
Principal Investigator: Andrea Claudio Comel, MD         
Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano. Recruiting
Milan, Italy, 20142
Contact: Michele Mondoni, MD    +390281843023    michele.mondoni@ao-sanpaolo.it   
Principal Investigator: Michele Mondoni, MD         
Sub-Investigator: Fabiano Di Marco, MD, PhD         
Sub-Investigator: Paolo Carlucci, MD         
Sub-Investigator: Elena Parazzini, MD         
Sub-Investigator: Giuseppe F Sferrazza Papa, MD         
Sub-Investigator: Sara Job, MD         
A.O.U. Maggiore della Carità - S.C.D.O. Pneumologia Recruiting
Novara, Italy
Contact: Piero Balbo, M.D.    03213733386    piero.balbo@libero.it   
Principal Investigator: Piero Balbo, M.D.         
Clinica Pneumotisiologica, AOU Sassari Recruiting
Sassari, Italy
Contact: Alessandro Fois, MD         
Principal Investigator: Alessandro Fois, MD         
Sponsors and Collaborators
University of Milan
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.
  More Information

No publications provided

Responsible Party: Fabiano Di Marco, M.D., Ph.D., University of Milan
ClinicalTrials.gov Identifier: NCT02045394     History of Changes
Other Study ID Numbers: HAEMOPTYSIS76
Study First Received: January 13, 2014
Last Updated: April 28, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
haemoptysis
hemoptysis
airway bleeding

Additional relevant MeSH terms:
Bronchiectasis
Bronchitis
Hemoptysis
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Bronchial Diseases
Gram-Positive Bacterial Infections
Hemorrhage
Mycobacterium Infections
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on October 30, 2014