UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059135 |
|---|---|
| Receipt number | R000067638 |
| Scientific Title | A Prospective Interventional Study on Initial Management of Epistaxis in the Emergency Department |
| Date of disclosure of the study information | 2025/09/19 |
| Last modified on | 2025/09/18 21:26:55 |
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Basic information
Public title
Study on Initial Management of Epistaxis in the Emergency Department
Acronym
Study on Initial Management of Epistaxis in the Emergency Department
Scientific Title
A Prospective Interventional Study on Initial Management of Epistaxis in the Emergency Department
Scientific Title:Acronym
Epistaxis Initial Care Study
Region
| Japan |
Condition
Condition
Epistaxis (Nosebleed)
Classification by specialty
| Oto-rhino-laryngology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was intended to show the differences in hemostasis between resolvable and non-resolvable packing materials, compare patients' demographics, and assess physicians' mental workloads during the treatment of epistaxis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hemostasis success rate (presence or absence of re-bleeding after initial emergency department management until otolaryngology evaluation on the following day).
Key secondary outcomes
Subjective Mental Workload (SMWL) score: mental demand, physical demand, time pressure, performance, effort, and frustration.
Pain score (10-point scale).
Procedure-related complications (e.g., mucosal injury, re-bleeding).
Identification of the bleeding site during initial management and accuracy confirmed by otolaryngologist evaluation.
Treatment accuracy of initial care as assessed by otolaryngologists.
Association of patient background factors (age, sex, blood pressure, use of antiplatelet/anticoagulant agents) with persistent bleeding.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Resorbable hemostatic material nasal packing
Interventions/Control_2
Non-resorbable gauze nasal packing
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults (above 18 years) presenting to the emergency department who required treatment for epistaxis.
Key exclusion criteria
Epistaxis due to multiple trauma or a consciousness disorder.Known hemorrhagic (bleeding) disorders.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Moteki |
Organization
Aizawa Hospital
Division name
Department of Otolaryngology
Zip code
390-8510
Address
2-5-1 Honjou Matsumoto, Nagano, Japan
TEL
0263-33-8600
hideaki.moteki@aizawa-hospital.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Moteki |
Organization
Aizawa Hospital
Division name
Department of Otolaryngology
Zip code
390-8510
Address
2-5-1 Honjou Matsumoto, Nagano, Japan
TEL
0263-33-8600
Homepage URL
hideaki.moteki@aizawa-hospital.jp
Sponsor or person
Institute
Aizawa Hospital, Department of Otolaryngology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of jisenkai
Address
2-5-1 Honjou Matsumoto, Nagano, Japan
Tel
0263-33-8600
kenkyu@ai-hosp.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
103
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067638
