- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02913365
Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis
Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis in a North-American Tertiary Center at the Beginning of the 21st Century
Study Overview
Status
Conditions
- Pathologic Processes
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia
- Hemorrhage
- Bronchiectasis
- Mycobacterium Infections
- Signs and Symptoms, Respiratory
- Lung Cancer
- Tuberculosis
- Lung Disease
- Bronchitis
- Pulmonary Embolism
- Arteriovenous Fistula
- Signs and Symptoms
- Pulmonary Hemorrhage
- Haemoptysis
- Hemoptysis
- Bronchial Disease
- Mycosis
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Brian Grondin-Beaudoin, MD
- Phone Number: 18193461110
- Email: brian.grondin.beaudoin@usherbrooke.ca
Study Contact Backup
- Name: Matthieu Poirier, MD
- Phone Number: 18193461110
- Email: matthieu.benoit.jose.poirier@usherbrooke.ca
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1G2E8
- Recruiting
- Centre Hospitalier Universitaire de Sherbrooke
-
Contact:
- Brian Grondin-Beaudoin, MD
- Phone Number: 18193461110
- Email: brian.grondin.beaudoin@usherbrooke.ca
-
Contact:
- Matthieu Poirier, MD
- Phone Number: 18193461110
- Email: matthieu.benoit.jose.poirier@usherbrooke.ca
-
Sub-Investigator:
- Amelie Blanchard, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 years
|
All-cause mortality at 2 years
Time Frame: 2 years
|
All-cause mortality at 2 years after the diagnosis of hemoptysis.
|
2 years
|
Smoking status
Time Frame: Day 1
|
Determining the percentage of patients who : never smoked, is an active smoker, former smoker or unknown status.
|
Day 1
|
Age
Time Frame: Day 1
|
Determining the average age of the enrolled patients.
|
Day 1
|
Gender
Time Frame: Day 1
|
Determining the percentage of each gender of the enrolled patients.
|
Day 1
|
International Normalized Ratio
Time Frame: Day 1
|
Determining the median of the international normalized ratio (INR).
|
Day 1
|
Partial Thromboplastin Time
Time Frame: Day 1
|
Determining the median of the partial thromboplastin time (PTT).
|
Day 1
|
Platelet count
Time Frame: Day 1
|
Determining the average of the platelet count measured per microliter of blood.
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian Grodin-Beaudoin, MD, Université de Sherbrooke
Publications and helpful links
General Publications
- Hirshberg B, Biran I, Glazer M, Kramer MR. Hemoptysis: etiology, evaluation, and outcome in a tertiary referral hospital. Chest. 1997 Aug;112(2):440-4. doi: 10.1378/chest.112.2.440.
- Jeudy J, Khan AR, Mohammed TL, Amorosa JK, Brown K, Dyer DS, Gurney JW, MacMahon H, Saleh AG, Vydareny KH; Expert Panel on Thoracic Imaging. ACR Appropriateness Criteria hemoptysis. J Thorac Imaging. 2010 Aug;25(3):W67-9. doi: 10.1097/RTI.0b013e3181e35b0c.
- Alaoui AY, Bartal M, el Boutahiri A, Bouayad Z, Bahlaoui A, el Meziane A, Naciri A. [Clinical characteristics and etiology in hemoptysis in a pneumology service. 291 cases]. Rev Mal Respir. 1992;9(3):295-300. French.
- Reechaipichitkul W, Latong S. Etiology and treatment outcomes of massive hemoptysis. Southeast Asian J Trop Med Public Health. 2005 Mar;36(2):474-80.
- Sanai Raggad S, Abid H, Ghedira H, Tritar F, Hamzaoui A. [Current etiologies of hemoptysis in the elderly: comparative study of 360 cases]. Tunis Med. 2010 Nov;88(11):809-13. French.
- Unsal E, Koksal D, Cimen F, Taci Hoca N, Sipit T. Analysis of patients with hemoptysis in a reference hospital for chest diseases. Tuberk Toraks. 2006;54(1):34-42.
- Prasad R, Garg R, Singhal S, Srivastava P. Lessons from patients with hemoptysis attending a chest clinic in India. Ann Thorac Med. 2009 Jan;4(1):10-2. doi: 10.4103/1817-1737.43062.
- Soares Pires F, Teixeira N, Coelho F, Damas C. Hemoptysis--etiology, evaluation and treatment in a university hospital. Rev Port Pneumol. 2011 Jan-Feb;17(1):7-14. doi: 10.1016/s2173-5115(11)70004-5. English, Portuguese.
- Pedrol E, Fernandez-Sola J, Ferrer M, Barcelo J, Bosch X, Sande L, Camp J, Borras A, Urbano-Marquez A. [Hemoptysis: a prospective study of 108 cases in an emergency service]. Rev Clin Esp. 1991 May;188(9):450-4. Spanish.
- Tsoumakidou M, Chrysofakis G, Tsiligianni I, Maltezakis G, Siafakas NM, Tzanakis N. A prospective analysis of 184 hemoptysis cases: diagnostic impact of chest X-ray, computed tomography, bronchoscopy. Respiration. 2006;73(6):808-14. doi: 10.1159/000091189. Epub 2006 Jan 27.
- Wong CM, Lim KH, Liam CK. The causes of haemoptysis in malaysian patients aged over 60 and the diagnostic yield of different investigations. Respirology. 2003 Mar;8(1):65-8. doi: 10.1046/j.1440-1843.2003.00437.x.
- Haro Estarriol M, Vizcaya Sanchez M, Jimenez Lopez J, Tornero Molina A. [Etiology of hemoptysis: Prospective analysis of 752 cases]. Rev Clin Esp. 2001 Dec;201(12):696-700. doi: 10.1016/s0014-2565(01)70953-8. Spanish.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Disease Attributes
- Congenital Abnormalities
- Embolism and Thrombosis
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Pathological Conditions, Anatomical
- Lung Diseases, Obstructive
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Bronchiectasis
- Lung Diseases
- Embolism
- Infections
- Communicable Diseases
- Mycobacterium Infections
- Hemorrhage
- Fistula
- Mycoses
- Tuberculosis
- Respiratory Tract Infections
- Pulmonary Embolism
- Bronchitis
- Respiratory Tract Diseases
- Arteriovenous Fistula
- Pathologic Processes
- Signs and Symptoms, Respiratory
- Bronchial Diseases
- Hemoptysis
Other Study ID Numbers
- 12-099
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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