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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02913365
Other study ID # 12-099
Secondary ID
Status Recruiting
Phase N/A
First received September 15, 2016
Last updated September 22, 2016
Start date October 2012
Est. completion date June 2017

Study information

Verified date September 2016
Source Université de Sherbrooke
Contact Brian Grondin-Beaudoin, MD
Phone 18193461110
Email brian.grondin.beaudoin@usherbrooke.ca
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms

  • Arteriovenous Fistula
  • Bronchial Disease
  • Bronchial Diseases
  • Bronchiectasis
  • Bronchitis
  • Communicable Diseases
  • Embolism
  • Fistula
  • Haemoptysis
  • Hemoptysis
  • Hemorrhage
  • Infection
  • Lung Cancer
  • Lung Disease
  • Lung Diseases
  • Mycobacterium Infections
  • Mycoses
  • Mycosis
  • Pathologic Processes
  • Pneumonia
  • Pulmonary Embolism
  • Pulmonary Hemorrhage
  • Respiratory Tract Diseases
  • Respiratory Tract Infections
  • Signs and Symptoms
  • Signs and Symptoms, Respiratory
  • Tuberculosis

Locations

Country Name City State
Canada Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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. — View Citation

Haro Estarriol M, Vizcaya Sánchez M, Jiménez López J, Tornero Molina A. [Etiology of hemoptysis: Prospective analysis of 752 cases]. Rev Clin Esp. 2001 Dec;201(12):696-700. Spanish. — View Citation

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. — View Citation

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. — View Citation

Pedrol E, Fernández-Solá J, Ferrer M, Barceló J, Bosch X, Sandé L, Camp J, Borrás A, Urbano-Márquez A. [Hemoptysis: a prospective study of 108 cases in an emergency service]. Rev Clin Esp. 1991 May;188(9):450-4. Spanish. — View Citation

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. — View Citation

Reechaipichitkul W, Latong S. Etiology and treatment outcomes of massive hemoptysis. Southeast Asian J Trop Med Public Health. 2005 Mar;36(2):474-80. — View Citation

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. — View Citation

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. English, Portuguese. — View Citation

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. Epub 2006 Jan 27. — View Citation

Unsal E, Köksal 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. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Etiologies of hemoptysis 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 No
Secondary Sensitivity of chest X-ray, chest CT-scan and CT-angiography, bronchoscopy, ventilation-perfusion with single-photon emission computed tomography and pulmonary angiography. 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 No
Secondary All-cause mortality at 2 years All-cause mortality at 2 years after the diagnosis of hemoptysis. 2 years No
Secondary Smoking status Determining the percentage of patients who : never smoked, is an active smoker, former smoker or unknown status. Day 1 No
Secondary Age Determining the average age of the enrolled patients. Day 1 No
Secondary Gender Determining the percentage of each gender of the enrolled patients. Day 1 No
Secondary International Normalized Ratio Determining the median of the international normalized ratio (INR). Day 1 No
Secondary Partial Thromboplastin Time Determining the median of the partial thromboplastin time (PTT). Day 1 No
Secondary Platelet count Determining the average of the platelet count measured per microliter of blood. Day 1 No
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