Clinical Trial: Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

Official Title: Multicenter, Prospective, Observational Study on Epidemiology and Diagnosis of Haemoptysis

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 Summary:
Sponsor: University of Milan

Current Primary Outcome: Percentage of patients presenting with haemoptysis affected by lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis or other causes. [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    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 ]
    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 ]
    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 ]
    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.


Original Secondary Outcome: Same as current

Information By: University of Milan

Dates:
Date Received: January 13, 2014
Date Started: June 2013
Date Completion:
Last Updated: December 2, 2015
Last Verified: December 2015