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Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study

NCT ID: NCT02045394

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

610 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Brief Summary

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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 Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients presenting with haemoptysis

Chest X-ray

Intervention Type OTHER

computed tomography of the chest

Intervention Type OTHER

Bronchoscopy

Intervention Type 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.

Interventions

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Chest X-ray

Intervention Type OTHER

computed tomography of the chest

Intervention Type OTHER

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.

Intervention Type PROCEDURE

Other Intervention Names

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chest CT scan

Eligibility Criteria

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Inclusion Criteria

* haemoptysis requiring a diagnosis

Exclusion Criteria

* history of known bleeding lesions in the upper or lower airways
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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Fabiano Di Marco

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michele Mondoni, MD

Role: PRINCIPAL_INVESTIGATOR

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

Paolo Carlucci, MD

Role: STUDY_CHAIR

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

Stefano Centanni, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

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Pneumologia, Azienda Ospedaliero Universitaria

Ancona, , Italy

Site Status

USC Pneumologia, Azienda Ospedaliera della Provincia di Lodi

Lodi, , Italy

Site Status

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

Mantova, , Italy

Site Status

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

Milan, , Italy

Site Status

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

Novara, , Italy

Site Status

Clinica Pneumotisiologica, AOU Sassari

Sassari, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 34348724 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30744616 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29301924 (View on PubMed)

Other Identifiers

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HAEMOPTYSIS76

Identifier Type: -

Identifier Source: org_study_id