EpistaxisEpistaxisNCT06906861
Epistaxis in Patients Receiving Oral Anticoagulants and Antiplatelet: Prevalence Risk Factors at a Tertiary Care Hospital in Nepal
An observational study of Epistaxis, run by Institute of medicine, Maharagjung medical campus at 1 site in Nepal.
Trial summary
This study aims to determine the prevalence of epistaxis and identify the associated risk factors among patients receiving oral anticoagulants and antiplatelet at a tertiary care hospital in Nepal. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Epistaxis
- How many people
- 284 participants
- Where
- 1 siteNepal
- Study dates
- 1 Nov 2023to 10 Nov 2024
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The individuals aged 40 years or older who had been prescribed oral anticoagulants or antiplatelet agents for at least 3 months, admitted at the depart of ENT or Emergency at TUTH were the study population of the study
Who may be able to join
- The study included individuals aged 40 years or older who had been prescribed oral anticoagulants or antiplatelet agents for at least 3 months.
Who cannot join
- Patients were excluded if they had a known bleeding disorder unrelated to the use of anticoagulant or antiplatelet medication, a history of coagulopathy or other bleeding disorders (e.g., hemophilia), recent craniofacial or nasal trauma or surgery within the past 6 months, a known history of nasal polyps or other nasal lesions, or if they declined to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to determine the prevalence of epistaxis and identify the associated risk factors among patients receiving oral anticoagulants and antiplatelet at a tertiary care hospital in Nepal.
A cross-sectional study was conducted among 284 patients receiving oral anticoagulants at a tertiary care hospital over a one-year period. Data were collected through structured interviews and medical record reviews. The prevalence of epistaxis with corresponding 95% CI was calculated, and risk factors were analyzed using multivariate logistic regression. A receiver operating characteristic (ROC) curve was determined to establish the suitability of the model.
Read the detailed description
Study Design and duration This study employed a hospital-based observational, cross-sectional design to determine the prevalence of epistaxis and identify the associated factors among patients on oral anticoagulants and antiplatelet medications at a tertiary care hospital in Nepal. The study was conducted at the department of emergency and ENT over a one-year period, from November 2023 to October 2024.
Study Setting and justification The study was conducted at the department of emergency and Ear Nose Throat (ENT) of Tribhuvan university teaching hospital (TUTH), Institute of Medicine (IOM), a tertiary care hospital of Nepal's premier healthcare institutions, situated in the heart of the capital city, Kathmandu. TUTH stands as the top referral hospital in the country and a public hospital in Kathmandu with 850 beds, which is recognized hospitals of Nepal with a good flow of patients from all over Nepal, making it easier to recruit a sufficient number of representing cases for the study. This hospital serves a diverse patient population across the country from both urban and rural areas, making an ideal setting for the representative samples to study on the prevalence and risk factors associated with epistaxis in patients taking anticoagulants and antiplatelet medications.
Study Population and selection criteria Inclusion and exclusion criteria The study included individuals aged 40 years or older who had been prescribed oral anticoagulants or antiplatelet agents for at least 3 months. Patients were excluded if they had a known bleeding disorder unrelated to the use of anticoagulant or antiplatelet medication, a history of coagulopathy or other bleeding disorders (e.g., hemophilia), recent craniofacial or nasal trauma or surgery within the past 6 months, a known history of nasal polyps or other nasal lesions, or if they declined to provide consent.
Variables of interest In this study, age, gender, residency, social habits, underlying medical conditions, types of anticoagulant and antiplatelet medications, and the duration of medication use were identified as exposure variables; whereas, the prevalence, severity, and frequency of epistaxis were evaluated as outcome variables.
Sample Size Determination
The sample size was determined using a Cochrane formula for cross-sectional studies (18):
N = Z2×P(1-P)
d2 where, Z is the Z-value corresponding to a 95% confidence level (1.96) P is the estimated prevalence of epistaxis in patients on anticoagulants/antiplatelet, based on previous, and d is the margin of error, set at 5%.
Assuming an estimated prevalence of epistaxis of 21% (19) and a 10% non-response rate, the final sample size was calculated to be 284 patients.
Sampling Method Patients were recruited through consecutive sampling from outpatient departments (ENT and Emergency) and inpatient wards. Recruitment continued until the calculated sample size was achieved.
Data Collection tool and technique Data were collected using a structured, pre-tested questionnaire administered through face-to-face interviews by trained research assistants, researcher and clinician involved in the study.
Data collection procedure:
The study initially identified potential participants from patients currently prescribed anticoagulant and antiplatelet medications who were visiting the ENT and Emergency Departments at TUTH. Informed consent was obtained from each participant prior to data collection. Socio-demographics including age, gender, occupation, place of residence, and lifestyle factors such as smoking and alcohol use were gathered. Relevant medical history was obtained from patient medical records, and, when necessary, interviews were conducted with patients or their relatives to gather information on comorbidities, history of epistaxis, frequency and severity of epistaxis, other bleeding episodes, and underlying medical conditions; Medication details, including Information on the types of medications and the duration of anticoagulant or antiplatelet therapy, which were obtained from medical and prescription records; clinical examination: A focused nasal examination was performed by an ENT specialist to assess for predisposing factors such as nasal septal deviation, mucosal dryness, and the presence of nasal polyps or other abnormalities Statistical Analysis Descriptive statistics were used to summarize the demographic and clinical characteristics of the study population. Continuous variables were expressed as means ± standard deviations (SD), while categorical variables were presented as frequencies and percentages. Bivariate analyses were conducted to explore associations between epistaxis and categorical variables using Chi-square tests or Fisher's exact tests, as appropriate, and independent t-tests or Mann-Whitney U tests were used for continuous variables. Variables with a p-value <0.05 in bivariate analysis were included in the logistic regression model. Crude and Adjusted odds ratios (AOR) with 95% confidence intervals (CI) were reported to identify the independent factors associated with the epistaxis. A p-value <0.05 was considered statistically significant in all analyses. All statistical analyses were conducted using SPSS, version 23 Ethical Considerations The study was approved by Institutional Review Committee (IRC- IOM), Institution of Medicine, Tribhuvan University prior to the commencement of the study. (Reference no. 263(6-11) E2, 080/081). Written informed consent was obtained from all participants before data collection. Confidentiality and privacy were ensured by anonymizing patient data and securing the database. Only the research team had access to the data. Patients who experienced active epistaxis during the study were provided with appropriate medical care, as per hospital protocol.
- Conditions
- Epistaxis
- Keywords
- Epistaxis, oral anticoagulants, antiplatelet, prevalence, risk factors, warfarin
- Medical subject headings
- Epistaxis
What is being measured
The primary outcome is the main question the study is designed to answer.
Epistaxis in Patients Receiving Oral Anticoagulants and Antiplatelet: Prevalence Risk Factors at a Tertiary Care Hospital in Nepal
This study aims to determine the prevalence of epistaxis and identify the associated risk factors among patients receiving oral anticoagulants and antiplatelet at a tertiary care hospital in Nepal.
Measured: The study was conducted at the department of emergency and ENT over a one-year period, from November 2023 to October 2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Nov 2023
- Primary completion10 Nov 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of medicine, Maharagjung medical campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiv Kumar Sah, Institute of medicine, Maharagjung medical campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906861
- Sponsor's protocol ID
- 263(6-11) E2, 080/081
- Other IDs
- 263(6-11) E2, 080/081
- Acronym
- Epistaxis
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epistaxis in Patients Receiving Oral Anticoagulants and Antiplatelet: Prevalence Risk Factors at a Tertiary Care Hospital in Nepal
- ClinicalTrials.gov ID
- NCT06906861
- Acronym / sponsor ID
- Epistaxis / 263(6-11) E2, 080/081
- Conditions
- Epistaxis
- Keywords
- Epistaxis, oral anticoagulants, antiplatelet, prevalence, risk factors, warfarin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Institute of medicine, Maharagjung medical campusUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 2 Apr 2025 (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.
This study aims to determine the prevalence of epistaxis and identify the associated risk factors among patients receiving oral anticoagulants and antiplatelet at a tertiary care hospital in Nepal.
A cross-sectional study was conducted among 284 patients receiving oral anticoagulants at a tertiary care hospital over a one-year period. Data were collected through structured interviews and medical record reviews. The prevalence of epistaxis with corresponding 95% CI was calculated, and risk factors were analyzed using multivariate logistic regression. A receiver operating characteristic (ROC) curve was determined to establish the suitability of the model.
Detailed description
Study Design and duration This study employed a hospital-based observational, cross-sectional design to determine the prevalence of epistaxis and identify the associated factors among patients on oral anticoagulants and antiplatelet medications at a tertiary care hospital in Nepal. The study was conducted at the department of emergency and ENT over a one-year period, from November 2023 to October 2024.
Study Setting and justification The study was conducted at the department of emergency and Ear Nose Throat (ENT) of Tribhuvan university teaching hospital (TUTH), Institute of Medicine (IOM), a tertiary care hospital of Nepal's premier healthcare institutions, situated in the heart of the capital city, Kathmandu. TUTH stands as the top referral hospital in the country and a public hospital in Kathmandu with 850 beds, which is recognized hospitals of Nepal with a good flow of patients from all over Nepal, making it easier to recruit a sufficient number of representing cases for the study. This hospital serves a diverse patient population across the country from both urban and rural areas, making an ideal setting for the representative samples to study on the prevalence and risk factors associated with epistaxis in patients taking anticoagulants and antiplatelet medications.
Study Population and selection criteria Inclusion and exclusion criteria The study included individuals aged 40 years or older who had been prescribed oral anticoagulants or antiplatelet agents for at least 3 months. Patients were excluded if they had a known bleeding disorder unrelated to the use of anticoagulant or antiplatelet medication, a history of coagulopathy or other bleeding disorders (e.g., hemophilia), recent craniofacial or nasal trauma or surgery within the past 6 months, a known history of nasal polyps or other nasal lesions, or if they declined to provide consent.
Variables of interest In this study, age, gender, residency, social habits, underlying medical conditions, types of anticoagulant and antiplatelet medications, and the duration of medication use were identified as exposure variables; whereas, the prevalence, severity, and frequency of epistaxis were evaluated as outcome variables.
Sample Size Determination
The sample size was determined using a Cochrane formula for cross-sectional studies (18):
N = Z2×P(1-P)
d2 where, Z is the Z-value corresponding to a 95% confidence level (1.96) P is the estimated prevalence of epistaxis in patients on anticoagulants/antiplatelet, based on previous, and d is the margin of error, set at 5%.
Assuming an estimated prevalence of epistaxis of 21% (19) and a 10% non-response rate, the final sample size was calculated to be 284 patients.
Sampling Method Patients were recruited through consecutive sampling from outpatient departments (ENT and Emergency) and inpatient wards. Recruitment continued until the calculated sample size was achieved.
Data Collection tool and technique Data were collected using a structured, pre-tested questionnaire administered through face-to-face interviews by trained research assistants, researcher and clinician involved in the study.
Data collection procedure:
The study initially identified potential participants from patients currently prescribed anticoagulant and antiplatelet medications who were visiting the ENT and Emergency Departments at TUTH. Informed consent was obtained from each participant prior to data collection. Socio-demographics including age, gender, occupation, place of residence, and lifestyle factors such as smoking and alcohol use were gathered. Relevant medical history was obtained from patient medical records, and, when necessary, interviews were conducted with patients or their relatives to gather information on comorbidities, history of epistaxis, frequency and severity of epistaxis, other bleeding episodes, and underlying medical conditions; Medication details, including Information on the types of medications and the duration of anticoagulant or antiplatelet therapy, which were obtained from medical and prescription records; clinical examination: A focused nasal examination was performed by an ENT specialist to assess for predisposing factors such as nasal septal deviation, mucosal dryness, and the presence of nasal polyps or other abnormalities Statistical Analysis Descriptive statistics were used to summarize the demographic and clinical characteristics of the study population. Continuous variables were expressed as means ± standard deviations (SD), while categorical variables were presented as frequencies and percentages. Bivariate analyses were conducted to explore associations between epistaxis and categorical variables using Chi-square tests or Fisher's exact tests, as appropriate, and independent t-tests or Mann-Whitney U tests were used for continuous variables. Variables with a p-value <0.05 in bivariate analysis were included in the logistic regression model. Crude and Adjusted odds ratios (AOR) with 95% confidence intervals (CI) were reported to identify the independent factors associated with the epistaxis. A p-value <0.05 was considered statistically significant in all analyses. All statistical analyses were conducted using SPSS, version 23 Ethical Considerations The study was approved by Institutional Review Committee (IRC- IOM), Institution of Medicine, Tribhuvan University prior to the commencement of the study. (Reference no. 263(6-11) E2, 080/081). Written informed consent was obtained from all participants before data collection. Confidentiality and privacy were ensured by anonymizing patient data and securing the database. Only the research team had access to the data. Patients who experienced active epistaxis during the study were provided with appropriate medical care, as per hospital protocol.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The individuals aged 40 years or older who had been prescribed oral anticoagulants or antiplatelet agents for at least 3 months, admitted at the depart of ENT or Emergency at TUTH were the study population of the study
Key inclusion criteria (1 listed)
- The study included individuals aged 40 years or older who had been prescribed oral anticoagulants or antiplatelet agents for at least 3 months.
Key exclusion criteria (1 listed)
- Patients were excluded if they had a known bleeding disorder unrelated to the use of anticoagulant or antiplatelet medication, a history of coagulopathy or other bleeding disorders (e.g., hemophilia), recent craniofacial or nasal trauma or surgery within the past 6 months, a known history of nasal polyps or other nasal lesions, or if they declined to provide consent.
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
Epistaxis in Patients Receiving Oral Anticoagulants and Antiplatelet: Prevalence Risk Factors at a Tertiary Care Hospital in Nepal
Time frame: The study was conducted at the department of emergency and ENT over a one-year period, from November 2023 to October 2024.
This study aims to determine the prevalence of epistaxis and identify the associated risk factors among patients receiving oral anticoagulants and antiplatelet at a tertiary care hospital in Nepal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Institute of medicine, Maharagjung medical campus at 1 site in Nepal.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Apr 2025. 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 Nepal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epistaxis in Patients Receiving Oral Anticoagulants and Antiplatelet: Prevalence Risk Factors at a Tertiary Care Hospital in Nepal (time frame: The study was conducted at the department of emergency and ENT over a one-year period, from November 2023 to October 2024.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2025.