EpistaxisFREANCT06657053
Risk Factors of Epistaxis Recurrence in Adults
An observational study of Epistaxis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
We study all patients admitted to the Emergency Department in the Institution between 01/2022 and 07/2023. The information about the recurrence of nose bleeding was searched on their medical file and by calling the patient to confirm ou get the information. Thus, several potentiel risk factors were studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epistaxis
- How many people
- 145 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2024to 1 Apr 2025
- How long will I take part?
- 1 Day
- 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: All the patientswho are admitted at the emergency department between 01/2022 and 07/2023
Who may be able to join
- Patient who is admitted at the emergency department between 01/2022 and 07/2023 for nose bleeding.
- Age over 18 yo
Who cannot join
- Opposition to be included
- Patient who has not his willness to provide opposition to participate.opposition
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Grenoble Alpes
La Tronche, ISERE, 38700
Ashley BAGUANT, Doctor, +33476764522, abaguant@chu-grenoble.fr
About this study
Official title: Facteurs De Risques De Récidive D'épistaxis Chez L'adulte
We study all patients admitted to the Emergency Department in the Institution between 01/2022 and 07/2023. The information about the recurrence of nose bleeding was searched on their medical file and by calling the patient to confirm ou get the information. Thus, several potentiel risk factors were studied.
The relation between recurrence and those factors were studied at first individually and then all the significant ones were analyzed with a multivarious statistical test.
Read the detailed description
We study all patients admitted to the Emergency Department in the Institution between 01/2022 and 07/2023. The information about the recurrence of nose bleeding was searched on their medical file and by calling the patient to confirm ou get the information. Thus, several potentiel risk factors were studied : oral anticoagulants, sex, INR, anti-platelets drugs, diabetes, obesity, arterial hypertension, heart failure, hemoglobin at the admission, history of chronic rhinosinusitis, appointment with an ENT during the acute bleeding, sleep apnea, age, anatomic abnormality, recent surgery within 2 months, previous admission within 30 days in the emergency department, nasal trauma.
The relation between recurrence and those factors were studied at first individually and then all the significant ones were analyzed with a multivarious statistical test.
This study aim to provide a pronostic score of recurrence that can happen after the 3 fisrt weeks after the event. When a recurrence happens before 3 weeks, this was considered to be a non control of the bleeding episode.
This score will be then tested on our cohort to evaluate specificity and sensibility.
- Conditions
- Epistaxis
- Keywords
- Risk Factors, Recurrent Epistaxis
- Medical subject headings
- Epistaxis
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 |
|---|---|---|
| Patient with nose bleeding | Evaluation of recurrence epistaxis during the year after a first episode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without bleeding
Measuring the delay between the first epistaxis and a recurrence.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start2 Nov 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Prospective
- Enrolment
- 145 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657053
- Sponsor's protocol ID
- EssaiClinique_FREA
- Acronym
- FREA
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Addison A, Paul C, Kuo R, Lamyman A, Martinez-Devesa P, Hettige R. Recurrent epistaxis: predicting risk of 30-day readmission, derivation and validation of RHINO-ooze score. Rhinology. 2017 Jun 1;55(2):99-105. doi: 10.4193/Rhin16.259.
PubMed 28434017Abrich V, Brozek A, Boyle TR, Chyou PH, Yale SH. Risk factors for recurrent spontaneous epistaxis. Mayo Clin Proc. 2014 Dec;89(12):1636-43. doi: 10.1016/j.mayocp.2014.09.009. Epub 2014 Nov 6.
PubMed 25458126Chaaban MR, Zhang D, Resto V, Goodwin JS. Factors influencing recurrent emergency department visits for epistaxis in the elderly. Auris Nasus Larynx. 2018 Aug;45(4):760-764. doi: 10.1016/j.anl.2017.11.010. Epub 2017 Dec 6.
PubMed 29208334Melia L, McGarry GW. Epistaxis: update on management. Curr Opin Otolaryngol Head Neck Surg. 2011 Feb;19(1):30-5. doi: 10.1097/MOO.0b013e328341e1e9.
PubMed 21150620Pino Rivero V, Trinidad Ruiz G, Gonzalez Palomino A, Pardo Romero G, Pantoja Hernandez CG, Marcos Garcia M, Keituqwa Yanez T, Blasco Huelva A. [Considerations about ENT emergencies. Analysis of 30000 patients assisted in 10 years]. Acta Otorrinolaringol Esp. 2005 May;56(5):198-201. doi: 10.1016/s0001-6519(05)78600-3. Spanish.
PubMed 15960122Pallin DJ, Chng YM, McKay MP, Emond JA, Pelletier AJ, Camargo CA Jr. Epidemiology of epistaxis in US emergency departments, 1992 to 2001. Ann Emerg Med. 2005 Jul;46(1):77-81. doi: 10.1016/j.annemergmed.2004.12.014.
PubMed 15988431Tunkel DE, Anne S, Payne SC, Ishman SL, Rosenfeld RM, Abramson PJ, Alikhaani JD, Benoit MM, Bercovitz RS, Brown MD, Chernobilsky B, Feldstein DA, Hackell JM, Holbrook EH, Holdsworth SM, Lin KW, Lind MM, Poetker DM, Riley CA, Schneider JS, Seidman MD, Vadlamudi V, Valdez TA, Nnacheta LC, Monjur TM. Clinical Practice Guideline: Nosebleed (Epistaxis). Otolaryngol Head Neck Surg. 2020 Jan;162(1_suppl):S1-S38. doi: 10.1177/0194599819890327.
PubMed 31910111Cohen O, Shoffel-Havakuk H, Warman M, Tzelnick S, Haimovich Y, Kohlberg GD, Halperin D, Lahav Y. Early and Late Recurrent Epistaxis Admissions: Patterns of Incidence and Risk Factors. Otolaryngol Head Neck Surg. 2017 Sep;157(3):424-431. doi: 10.1177/0194599817705619. Epub 2017 May 2.
PubMed 28463569
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facteurs De Risques De Récidive D'épistaxis Chez L'adulte
- ClinicalTrials.gov ID
- NCT06657053
- Acronym / sponsor ID
- FREA / EssaiClinique_FREA
- Conditions
- Epistaxis
- Keywords
- Risk Factors, Recurrent Epistaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 2 Nov 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 24 Oct 2024 (actual)
- 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.
We study all patients admitted to the Emergency Department in the Institution between 01/2022 and 07/2023. The information about the recurrence of nose bleeding was searched on their medical file and by calling the patient to confirm ou get the information. Thus, several potentiel risk factors were studied.
The relation between recurrence and those factors were studied at first individually and then all the significant ones were analyzed with a multivarious statistical test.
Detailed description
We study all patients admitted to the Emergency Department in the Institution between 01/2022 and 07/2023. The information about the recurrence of nose bleeding was searched on their medical file and by calling the patient to confirm ou get the information. Thus, several potentiel risk factors were studied : oral anticoagulants, sex, INR, anti-platelets drugs, diabetes, obesity, arterial hypertension, heart failure, hemoglobin at the admission, history of chronic rhinosinusitis, appointment with an ENT during the acute bleeding, sleep apnea, age, anatomic abnormality, recent surgery within 2 months, previous admission within 30 days in the emergency department, nasal trauma.
The relation between recurrence and those factors were studied at first individually and then all the significant ones were analyzed with a multivarious statistical test.
This study aim to provide a pronostic score of recurrence that can happen after the 3 fisrt weeks after the event. When a recurrence happens before 3 weeks, this was considered to be a non control of the bleeding episode.
This score will be then tested on our cohort to evaluate specificity and sensibility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with nose bleeding | – | –Evaluation of recurrence epistaxis during the year after a first episode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patientswho are admitted at the emergency department between 01/2022 and 07/2023
Key inclusion criteria (2 listed)
- Patient who is admitted at the emergency department between 01/2022 and 07/2023 for nose bleeding.
- Age over 18 yo
Key exclusion criteria (2 listed)
- Opposition to be included
- Patient who has not his willness to provide opposition to participate.opposition
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
Survival without bleeding
Time frame: 1 year
Measuring the delay between the first epistaxis and a recurrence.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Background: PubMed 28434017Addison A, Paul C, Kuo R, Lamyman A, Martinez-Devesa P, Hettige R. Recurrent epistaxis: predicting risk of 30-day readmission, derivation and validation of RHINO-ooze score. Rhinology. 2017 Jun 1;55(2):99-105. doi: 10.4193/Rhin16.259.
- Background: PubMed 25458126Abrich V, Brozek A, Boyle TR, Chyou PH, Yale SH. Risk factors for recurrent spontaneous epistaxis. Mayo Clin Proc. 2014 Dec;89(12):1636-43. doi: 10.1016/j.mayocp.2014.09.009. Epub 2014 Nov 6.
- Background: PubMed 29208334Chaaban MR, Zhang D, Resto V, Goodwin JS. Factors influencing recurrent emergency department visits for epistaxis in the elderly. Auris Nasus Larynx. 2018 Aug;45(4):760-764. doi: 10.1016/j.anl.2017.11.010. Epub 2017 Dec 6.
- Background: PubMed 21150620Melia L, McGarry GW. Epistaxis: update on management. Curr Opin Otolaryngol Head Neck Surg. 2011 Feb;19(1):30-5. doi: 10.1097/MOO.0b013e328341e1e9.
- Background: PubMed 15960122Pino Rivero V, Trinidad Ruiz G, Gonzalez Palomino A, Pardo Romero G, Pantoja Hernandez CG, Marcos Garcia M, Keituqwa Yanez T, Blasco Huelva A. [Considerations about ENT emergencies. Analysis of 30000 patients assisted in 10 years]. Acta Otorrinolaringol Esp. 2005 May;56(5):198-201. doi: 10.1016/s0001-6519(05)78600-3. Spanish.
- Background: PubMed 15988431Pallin DJ, Chng YM, McKay MP, Emond JA, Pelletier AJ, Camargo CA Jr. Epidemiology of epistaxis in US emergency departments, 1992 to 2001. Ann Emerg Med. 2005 Jul;46(1):77-81. doi: 10.1016/j.annemergmed.2004.12.014.
- Background: PubMed 31910111Tunkel DE, Anne S, Payne SC, Ishman SL, Rosenfeld RM, Abramson PJ, Alikhaani JD, Benoit MM, Bercovitz RS, Brown MD, Chernobilsky B, Feldstein DA, Hackell JM, Holbrook EH, Holdsworth SM, Lin KW, Lind MM, Poetker DM, Riley CA, Schneider JS, Seidman MD, Vadlamudi V, Valdez TA, Nnacheta LC, Monjur TM. Clinical Practice Guideline: Nosebleed (Epistaxis). Otolaryngol Head Neck Surg. 2020 Jan;162(1_suppl):S1-S38. doi: 10.1177/0194599819890327.
- Background: PubMed 28463569Cohen O, Shoffel-Havakuk H, Warman M, Tzelnick S, Haimovich Y, Kohlberg GD, Halperin D, Lahav Y. Early and Late Recurrent Epistaxis Admissions: Patterns of Incidence and Risk Factors. Otolaryngol Head Neck Surg. 2017 Sep;157(3):424-431. doi: 10.1177/0194599817705619. Epub 2017 May 2.
- Individual participant dataSharing planned: No
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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.
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 Epistaxis, run by University Hospital, Grenoble at 1 site in France.
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 2 inclusion and 2 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 24 Oct 2024. 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 France. 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 Ashley BAGUANT, Doctor (+33476764522, abaguant@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without bleeding (time frame: 1 year). 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 NCT06657053, which also lists 8 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 24 Oct 2024.