This study aims to evaluate the effect of the local use of tranexamic acid in the control of epistaxis.
Design
It was randomized, placebo-controlled, with parallel groups, triple-blind, phase 2-3 trial on 106 patients. The randomization website was used for randomization.
Settings and conduct
In this study, patients who come to the ER of two tertiary hospitals are selected. The initial diagnosis of epistaxis is performed by an emergency medicine specialist, and after obtaining informed consent, the eligible patients are randomly assigned to the drug or placebo group. To blind the care providers and participants, both solutions are prepared with the same shape and color, and they are not aware of the contents of the prescribed solution. With the control of epistaxis, they discharged with nasal sprays.
Participants/Inclusion and exclusion criteria
The participants in this study are patients over 18 years old who have spontaneous nosebleeds (not following trauma) and do not have underlying diseases (e.g. sinonasal or nasopharynx malignancy). Those who do not agree to enroll or are considered high-risk groups in terms of drug prescription will be excluded from the study.
Intervention groups
In the interventional group, participants were discharged with tranexamic acid nasal spray after ceasing epistaxis with primary conservative management for 3 days. The first dose is sprayed in the emergency room. Patients in the control group are discharged after nosebleeds cease due to primary treatments with sodium chloride 0.9% prepared as a nasal spray. It is prescribed as the same as the interventional group.
Main outcome variables
The primary outcome is the number of patients with control of bleeding within 7 days in each group. The essential secondary outcomes are the time to stop bleeding after intervention, the rate of rebleeding within 24 hours, and the rate of adverse events within 7 days.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221230056992N1
Registration date:2023-12-18, 1402/09/27
Registration timing:registered_while_recruiting
Last update:2023-12-18, 1402/09/27
Update count:0
Registration date
2023-12-18, 1402/09/27
Registrant information
Name
seyed ermia mousavi mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 4082
Email address
ermiamsm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-12-05, 1403/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of topical tranexamic acid in the control of acute epistaxis
Public title
Effect of topical tranexamic acid in the treatment of epistaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with acute spontaneous epistaxis
age more than 18
epistaxis is controlled with primary conservative management
patient has a consent to enroll the study
Exclusion criteria:
sensitivity to tranexamic acid
no consent to enroll the study
there is any malignancy in the nasopharynx, nasal cavity or sinonasal tract
prior packing in nasal cavities when come to ER
pregnancy or breastfeeding
history of coagulopathies
hemodynamic instability
second stage of hypertension (SBP>=160 and DBP>=100)
epistaxis following trauma
history of recent myocardial infarction or stroke
renal dysfunction
history of thromboembolism or seizure
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
It is prepared for the random assignment of random numbers with the help of 'randomization.com'. The opaque closed envelope method is used for random concealment. In this method, randomly assigned numbers are written in order and placed inside the envelope. The contents of the envelope will not be visible from the outside. For each patient, after entering the study and obtaining consent, an envelope is opened, and based on the envelope's contents, the individual is placed in the intervention or control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants and care providers are blind due to the drug and placebo provide in the same color and matter, it is presented to them with "A" or "B" stickers. Data are also given to data analyser in the two forms of "A" or "B".
Placebo
Used
Assignment
Parallel
Other design features
There is no study assessing the effect of tranexamic acid nasal spray in the control of epistaxis in Iran, yet.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Faculty of Medicine of Mashhad University of Medical Sciences
Street address
East door of University Campus, Azadi square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2023-05-02, 1402/02/12
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.081
Health conditions studied
1
Description of health condition studied
Haemorrhage from nose, Nosebleed
ICD-10 code
R04.0
ICD-10 code description
Epistaxis
Primary outcomes
1
Description
Number of patients without recurrent epistaxis during 7 days
Timepoint
first day, days 3 and 7 after intervention
Method of measurement
participants statement
Secondary outcomes
1
Description
Time to control bleeding
Timepoint
minutes to hours after intervention
Method of measurement
physical examination
2
Description
occurrence of side effects during 7 days
Timepoint
7 days after intervention
Method of measurement
patient statement
Intervention groups
1
Description
Intervention group: Tranexamic acid ampule (100 mg/ml) is prepared as a nasal spray and its volume is 5cc given 5 puffs every 12 hours for 3 days.
Category
Treatment - Drugs
2
Description
Control group: Sodium chloride (0.9 percent) was prepared as a nasal spray with a volume of 5cc, prescribed 5 puffs every 12 hours for 3 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Ermia Mousavi
Street address
Emamreza Hospital Square, Ibn Sina Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
MDS.Dean@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Ermia Mousavi
Street address
Ahmad Abad Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafagodi
Street address
Ghoreishi Building, Close to Howveizeh Cinema, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohamadreza Majidi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ahmad Abad Ave, Ghaem Hospital, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3859 4082
Email
majidiMR@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohamadreza Majidi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ahmad Abad Ave, Ghaem Hospital, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3859 4082
Email
majidiMR@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed ermia Mousavi mohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ahmad Abad Ave, Ghaem Hospital, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3859 4082
Fax
Email
ermiamsm@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Title: "Data of participants in effects of TA on Epistaxis control study"
All collected deidentified data (IPD) are accessible.
When the data will become available and for how long
Documents will be accessible one year after publishing.
To whom data/document is available
this is only available for people working in academic institutions.
Under which criteria data/document could be used
It will only be presented for familiarization with the data collection process, and analysis of the data will not be permitted.
From where data/document is obtainable
Applicant investigators could contact us with email addresses.
What processes are involved for a request to access data/document
The applicant will receive an email with the file containing the IPD within one month of requesting it.