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NCT Number: NCT02045394

Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study

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.

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Key information

Conditions

Lung Cancer Actinomycetales Infections Acute Bronchitis Bacterial Infections Bacterial Infections and Mycoses Bronchial Diseases Bronchiectasis Bronchitis Chronic Disease Chronic Obstructive Pulmonary Disease Cryptogenic Haemoptysis Disease Attributes Gram-Positive Bacterial Infections Hemoptysis Hemorrhage Infections Lung Diseases Lung Diseases, Obstructive Lung Neoplasms Mycobacterium Infections Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections Respiratory Tract Neoplasms Signs and Symptoms Signs and Symptoms, Respiratory Thoracic Neoplasms Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pneumologia, Azienda Ospedaliero Universitaria, Ancona, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • haemoptysis requiring a diagnosis

Exclusion criteria

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

Treatment and study plan

Chest X-ray

Other

computed tomography of the chest

Other

Other names: chest CT scan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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.

  3. 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).

  4. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
First posted
Jan 24, 2014
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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