HemoptysisNCT02913365
Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis
An observational study of Hemoptysis and Haemoptysis, run by Université de Sherbrooke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemoptysis, Haemoptysis, Lung Disease
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients under 18 years of age.
- Patient who refused investigation for hemoptysis.
- Incomplete medical chart
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1G2E8
Brian Grondin-Beaudoin, MD, 18193461110, brian.grondin.beaudoin@usherbrooke.ca
Matthieu Poirier, MD, 18193461110, matthieu.benoit.jose.poirier@usherbrooke.ca
About this study
Official title: Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis in a North-American Tertiary Center at the Beginning of the 21st Century
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.
Read the 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.
- Conditions
- Hemoptysis, Haemoptysis, Lung Disease, Pneumonia, Tuberculosis, Bronchiectasis
- Keywords
- Haemoptysis, Hemoptysis, Airway bleeding, Pulmonary hemorrhage
- Medical subject headings
- Hemoptysis, Lung Diseases, Pneumonia, Tuberculosis, Bronchiectasis, Respiratory Tract Infections, Respiratory Tract Diseases, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (8)
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.
Measured: 5 years
All-cause mortality at 2 years
All-cause mortality at 2 years after the diagnosis of hemoptysis.
Measured: 2 years
Smoking status
Determining the percentage of patients who : never smoked, is an active smoker, former smoker or unknown status.
Measured: Day 1
Age
Determining the average age of the enrolled patients.
Measured: Day 1
Gender
Determining the percentage of each gender of the enrolled patients.
Measured: Day 1
International Normalized Ratio
Determining the median of the international normalized ratio (INR).
Measured: Day 1
Partial Thromboplastin Time
Determining the median of the partial thromboplastin time (PTT).
Measured: Day 1
Platelet count
Determining the average of the platelet count measured per microliter of blood.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startOct 2012
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HemoptysisStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Grondin-Beaudoin, Université de Sherbrooke
- Investigators
- Brian Grodin-Beaudoin, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913365
- Sponsor's protocol ID
- 12-099
- Status last verified
- Sep 2016
- First submitted
- 15 Sep 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 9266882Jeudy 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.
PubMed 20711032Alaoui 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.
PubMed 1615202Reechaipichitkul W, Latong S. Etiology and treatment outcomes of massive hemoptysis. Southeast Asian J Trop Med Public Health. 2005 Mar;36(2):474-80.
PubMed 15916059Sanai 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.
PubMed 21049410Unsal 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.
PubMed 16615016Prasad 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.
PubMed 19561915Soares 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.
PubMed 21251478Pedrol 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.
PubMed 1896592Tsoumakidou 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.
PubMed 16446530Wong 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.
PubMed 12856744Haro 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.
PubMed 11835879
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis in a North-American Tertiary Center at the Beginning of the 21st Century
- ClinicalTrials.gov ID
- NCT02913365
- Acronym / sponsor ID
- 12-099
- Conditions
- Hemoptysis, Haemoptysis, Lung Disease, Pneumonia, Tuberculosis, Bronchiectasis
- Keywords
- Haemoptysis, Hemoptysis, Airway bleeding, Pulmonary hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Patients under 18 years of age.
- Patient who refused investigation for hemoptysis.
- Incomplete medical chart
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
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
All-cause mortality at 2 years
Time frame: 2 years
Smoking status
Time frame: Day 1
Age
Time frame: Day 1
Gender
Time frame: Day 1
International Normalized Ratio
Time frame: Day 1
Partial Thromboplastin Time
Time frame: Day 1
Platelet count
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Background: PubMed 9266882Hirshberg 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.
- Background: PubMed 20711032Jeudy 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.
- Background: PubMed 1615202Alaoui 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.
- Background: PubMed 15916059Reechaipichitkul W, Latong S. Etiology and treatment outcomes of massive hemoptysis. Southeast Asian J Trop Med Public Health. 2005 Mar;36(2):474-80.
- Background: PubMed 21049410Sanai 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.
- Background: PubMed 16615016Unsal 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.
- Background: PubMed 19561915Prasad 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.
- Background: PubMed 21251478Soares 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.
- Background: PubMed 1896592Pedrol 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.
- Background: PubMed 16446530Tsoumakidou 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.
- Background: PubMed 12856744Wong 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.
- Background: PubMed 11835879Haro 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.
- Individual participant dataSharing planned: Undecided
Related trials for Hemoptysis
Not yet recruitingObservational study
Chinese Hemoptysis Registry Study
Hemoptysis
Enrolling by invitationPhase 4
Comparison Between Efficacy of Inhaled VS Intravenous Tranexamic Acid for Hemoptysis
Hemoptysis
RecruitingObservational study
Tracheal Cuff Pressure and Postoperative Complications
Tracheal Intubation, Postoperative Complications (Cardiopulmonary)
Not yet recruitingObservational study
HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding
Hemorrhage, Gastrointestinal Hemorrhage
Not yet recruitingPhase 3
Nebulized Versus Intravenous Tranexamic Acid for Hemoptysis
Hemoptysis, Pulmonary Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Grodin-Beaudoin, MD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemoptysis and Haemoptysis, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Grondin-Beaudoin, MD (18193461110, brian.grondin.beaudoin@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Etiologies of hemoptysis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02913365, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.