Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study

December 2, 2015 updated by: Fabiano Di Marco, University of Milan

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

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

610

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ancona, Italy
        • Pneumologia, Azienda Ospedaliero Universitaria
      • Lodi, Italy
        • USC Pneumologia, Azienda Ospedaliera della Provincia di Lodi
      • Mantova, Italy
        • U.O. di Pnuemologia, Azienda Ospedaliera, Carlo Poma
      • Milan, Italy, 20142
        • Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano.
      • Novara, Italy
        • A.O.U. Maggiore della Carità - S.C.D.O. Pneumologia
      • Sassari, Italy
        • Clinica Pneumotisiologica, AOU Sassari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • haemoptysis requiring a diagnosis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients presenting with haemoptysis
Other Names:
  • chest CT scan
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
18 months
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.
18 months
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).
18 months
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.
18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Distribution of main causes of haemoptysis in the subgroup of patients undergoing medical therapies that increase the risk of bleeding.
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (ESTIMATE)

January 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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