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Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis

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ClinicalTrials.gov Identifier: NCT02913365
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study consist of a retrospective analysis of the etiologies, investigations and outcomes of patients presenting between 2005 to 2010 with hemoptysis in a North-American Tertiary center.

Condition or disease
Hemoptysis Haemoptysis Lung Disease Pneumonia Tuberculosis Bronchiectasis Respiratory Tract Infections Respiratory Tract Diseases Bronchitis Mycobacterium Infections Bronchial Disease Pulmonary Hemorrhage Signs and Symptoms Signs and Symptoms, Respiratory Pathologic Processes Mycosis Hemorrhage Lung Cancer Pulmonary Embolism Arteriovenous Fistula

Detailed Description:

RATIONALE:

Hemoptysis, mild or massive, is worrisome for both patients and physicians. The management is different depending on the causes, which are not well defined for the North American population. Despite the fact that this symptom is commonly reported in clinic, there are only a few studies published on this subject in the North-American population. Tuberculosis was a frequent cause of hemoptysis described in populations overseas, which seems less prevalent in the investigators center.

Also, there are no known official guidelines regarding the investigation and management of hemoptysis. The investigators hypothesized that the use of modern technology in a North American population may result in different findings and provide a more accurate diagnostic approach.

Therefore, the study compares the different etiologies of hemoptysis and investigation modalities used in patients presenting in a North-American tertiary center.

METHOD:

The investigators did a retrospective analysis of medical chart from patients with hemoptysis who visited the investigators center between 2005 and 2010. Each visit has been reviewed individually to describe the characteristics of patients, etiologies of hemoptysis and investigation modalities used. All-cause mortality at 2 years was also recorded.

Descriptive statistical analyses will conducted on the data available.


Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis in a North-American Tertiary Center at the Beginning of the 21st Century
Study Start Date : October 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Patients presenting with hemoptysis
Patients over 18 years of age presenting with hemoptysis at the Centre Hospitalier Universitaire de Sherbrooke (CHUS) between the periods of 2005 to 2010.


Outcome Measures

Primary Outcome Measures :
  1. Etiologies of hemoptysis [ Time Frame: 5 years ]
    Defining the prevalence of pulmonary diseases by measuring the percentage of patients presenting with hemoptysis caused by lung cancer, bronchiectasis, pulmonary embolism, arteriovenous fistula, pneumonia, bronchitis, tuberculosis, mycosis, heart failure, pseudohemoptysis, cryptogenic and other causes.


Secondary Outcome Measures :
  1. Sensitivity of chest X-ray, chest CT-scan and CT-angiography, bronchoscopy, ventilation-perfusion with single-photon emission computed tomography and pulmonary angiography. [ Time Frame: 5 years ]
    Determining the sensitivity in obtaining the etiology of the hemoptysis episode of each diagnostic modality that follows : chest X-ray, chest CT-scan and CT-angiography, bronchoscopy, ventilation-perfusion with single-photon emission computed tomography and pulmonary angiography in the diagnosis of different etiologies of hemoptysis.

  2. All-cause mortality at 2 years [ Time Frame: 2 years ]
    All-cause mortality at 2 years after the diagnosis of hemoptysis.

  3. Smoking status [ Time Frame: Day 1 ]
    Determining the percentage of patients who : never smoked, is an active smoker, former smoker or unknown status.

  4. Age [ Time Frame: Day 1 ]
    Determining the average age of the enrolled patients.

  5. Gender [ Time Frame: Day 1 ]
    Determining the percentage of each gender of the enrolled patients.

  6. International Normalized Ratio [ Time Frame: Day 1 ]
    Determining the median of the international normalized ratio (INR).

  7. Partial Thromboplastin Time [ Time Frame: Day 1 ]
    Determining the median of the partial thromboplastin time (PTT).

  8. Platelet count [ Time Frame: Day 1 ]
    Determining the average of the platelet count measured per microliter of blood.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any patient presenting with hemoptysis at the Centre Hospitalier Universitaire de Sherbrooke on an outpatient basis, emergency department or hospitalized at hopital Fleurimont or Hotel-Dieu of Sherbrooke.
Criteria

Inclusion Criteria:

Any patient over the age of 18 presenting with:

  • A diagnosis of hemoptysis on an outpatient basis.
  • A diagnosis of hemoptysis during consultation in the emergency department.
  • A diagnosis of hemoptysis on the admission sheet.
  • A diagnosis of hemoptysis when hospitalized.
  • A complication of hemoptysis
  • Hemoptysis on the report of the bronchoscopy, chest computed tomography, pulmonary angiography, ventilation-perfusion single-photon emission computed tomography or blood transfusion.

Exclusion Criteria:

  • Patients under 18 years of age.
  • Patient who refused investigation for hemoptysis.
  • Incomplete medical chart
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913365


Contacts
Contact: Brian Grondin-Beaudoin, MD 18193461110 brian.grondin.beaudoin@usherbrooke.ca
Contact: Matthieu Poirier, MD 18193461110 matthieu.benoit.jose.poirier@usherbrooke.ca

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1G2E8
Contact: Brian Grondin-Beaudoin, MD    18193461110    brian.grondin.beaudoin@usherbrooke.ca   
Contact: Matthieu Poirier, MD    18193461110    matthieu.benoit.jose.poirier@usherbrooke.ca   
Sub-Investigator: Amelie Blanchard, MD         
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Brian Grodin-Beaudoin, MD Université de Sherbrooke
More Information

Publications:

Responsible Party: Brian Grondin-Beaudoin, Medical Doctor, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02913365     History of Changes
Other Study ID Numbers: 12-099
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Brian Grondin-Beaudoin, Université de Sherbrooke:
Haemoptysis
Hemoptysis
Airway bleeding
Pulmonary hemorrhage

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumonia
Hemorrhage
Tuberculosis
Lung Diseases
Embolism
Mycoses
Fistula
Pulmonary Embolism
Respiratory Tract Infections
Bronchitis
Bronchiectasis
Mycobacterium Infections
Signs and Symptoms
Arteriovenous Fistula
Respiratory Tract Diseases
Pathologic Processes
Hemoptysis
Bronchial Diseases
Signs and Symptoms, Respiratory
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Lung Diseases, Obstructive
Arteriovenous Malformations