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Secondary outcomes
#1
need for blood transfusion or surgical intervention
rebleeding within 24 hours after presenting to ED
need for blood transfusion or surgical interventionrebleeding within 24 hours after presenting to ED
نیاز به تزریق خون یا مداخله جراحی
خون ریزی مجدد در 24 ساعت بعد از مراجعه به اورژانس
نیازخون ریزی مجدد در 24 ساعت بعد از مراجعه به تزریق خون یا مداخله جراحیاورژانس
at any time during ED attendance after initial intervention
within 24 hours after treatment
at any time during ED attendancewithin 24 hours after initial interventiontreatment
در هر زمان از حضور در اورژانس بعد از مداخله اولیه
در 24 ساعت بعد از درمان
در هر زمان از حضور در اورژانس24 ساعت بعد از مداخله اولیهدرمان
determined by clinical judgment of physician
self-statement of the patient with telephone call
determined by clinical judgmentself-statement of physicianthe patient with telephone call
بر اساس قضاوت بالینی پزشک معالج
خوداظهاری بیمار با تماس تلفنی
بر اساس قضاوت بالینی پزشک معالجخوداظهاری بیمار با تماس تلفنی
#2
rebleeding within 24 hours after presenting to ED
rebleeding within 1-7 days after presenting to ED
rebleeding within 24 hours1-7 days after presenting to ED
خون ریزی مجدد در 24 ساعت بعد از مراجعه به اورژانس
خون ریزی مجدد در 1-7 روز بعد از مراجعه به اورژانس
خون ریزی مجدد در 24 ساعت1-7 روز بعد از مراجعه به اورژانس
within 24 hours after treatment
1-7 days after presenting to ED
within 24 hours1-7 days after treatmentpresenting to ED
در 24 ساعت بعد از درمان
در 1-7 روز بعد از مراجعه به اورژانس
در 24 ساعت1-7 روز بعد از درمانمراجعه به اورژانس
#3
rebleeding within 1-7 days after presenting to ED
ED stay more than 2 hours
rebleeding within 1-7 days after presenting to ED stay more than 2 hours
خون ریزی مجدد در 1-7 روز بعد از مراجعه به اورژانس
مدت ماندن در اورژانس بیشتر از 2 ساعت
خون ریزی مجددمدت ماندن در 1-7 روز بعداورژانس بیشتر از مراجعه به اورژانس2 ساعت
1-7 days after presenting to ED
from presenting to ED to leaving the hospital
1-7 days afterfrom presenting to ED to leaving the hospital
در 1-7 روز بعد از مراجعه به اورژانس
از زمان ورود به اورژانس تا خروج از بیمارستان
در 1-7 روز بعد از مراجعهزمان ورود به اورژانس تا خروج از بیمارستان
self-statement of the patient with telephone call
This outcome variable will be evaluated and reported as a qualitative variable. The patients who have been discharged from ED after 2 hours from the presentation will be considered as positive cases for this variable.
self-statement ofThis outcome variable will be evaluated and reported as a qualitative variable. The patients who have been discharged from ED after 2 hours from the patient with telephone callpresentation will be considered as positive cases for this variable.
خوداظهاری بیمار با تماس تلفنی
این متغیر به صورت یک متغیر کیفی ارزیابی و گزارش می شود. بیمارانی که بعد از 2 ساعت از ورود به اورژانس، مرخص می شوند به عنوان مورد مثبت این متغیر در نظر گرفته می شوند.
خوداظهاری بیمار با تماس تلفنیاین متغیر به صورت یک متغیر کیفی ارزیابی و گزارش می شود. بیمارانی که بعد از 2 ساعت از ورود به اورژانس، مرخص می شوند به عنوان مورد مثبت این متغیر در نظر گرفته می شوند.
#4
duration of ED stay
empty
duration of ED stay
مدت ماندن در اورژانس
empty
مدت ماندن در اورژانس
from presenting to ED to leaving the hospital
empty
from presenting to ED to leaving the hospital
از زمان ورود به اورژانس تا خروج از بیمارستان
empty
از زمان ورود به اورژانس تا خروج از بیمارستان
clock (hours)
empty
clock (hours)
ساعت (بر حسب ساعت)
empty
ساعت (بر حسب ساعت)
Protocol summary
Study aim
The aim of the study is to evaluate the effectiveness of topical
intranasal TXA in reducing the need for long- term anterior nasal
packing in adult patients presenting to the ED with spontaneous
atraumatic epistaxis.
Design
A phase 3 randomized, single-blind, parallel-group controlled single-center trial on 240 participants.Randomization will be done by computerized block randomization by SPSS version 23.
Settings and conduct
This single-blind (only the participants are blinded) randomized (with block randomization method) controlled trial will be carried out on 240 patients with spontaneous atraumatic anterior epistaxis presenting to ENT ED of Khalili Hospital affiliated to Shiraz University of Medical Sciences, Iran. The patients will be divided into two groups: one group receives topical intranasal tranexamic acid and the other group does not.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged 18 or over; presenting to the emergency department (ED) with spontaneous, atraumatic anterior epistaxis, unresolved with simple first aid.
Exclusion criteria: hemodynamically unstable; allergy to tranexamic acid; a known nasopharyngeal, nasal cavity or paranasal malignancy; epistaxis caused by trauma; any known bleeding disorder.
Intervention groups
In the intervention group, cotton mesh soaked into tranexamic acid along with lidocaine and phenylephrine will be applied into the nose. In the control group, the cotton mesh will be soaked into lidocaine and phenylephrine alone.
Main outcome variables
Need for anterior nasal packing
General information
Reason for update
Regarding the fact that the clinical trial registered sooner than what the investigators expected, the study will be expected to start on 21 April 2021.
Also, due to the busy ED, it is not practically possible to assess the time of stopping bleeding. Therefore, this outcome will not be measured in the trial.
The investigators decided to change the trial from single-blinded to double-blinded. Also, recent use of any anticoagulant drug will be added to the exclusion criteria
Acronym
IRCT registration information
IRCT registration number:IRCT20210403050815N1
Registration date:2021-04-10, 1400/01/21
Registration timing:prospective
Last update:2021-08-30, 1400/06/08
Update count:3
Registration date
2021-04-10, 1400/01/21
Registrant information
Name
reza jahangiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3629 1470
Email address
rjahangiri62@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the ٍeffect of Topical Intranasal Tranexamic Acid for Stopping Nose Bleeding in Patients with Epistaxis in the ENT Emergency Department
Public title
Topical Intranasal Tranexamic Acid in Epistaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 or over
Presenting to the Ear, Nose, and Throat emergency department (ED) with spontaneous, atraumatic anterior epistaxis, unresolved with simple first aid
Exclusion criteria:
Hemodynamically unstable
Known allergy to tranexamic acid
Lacking capacity or unwilling to give consent
Known nasopharyngeal, nasal cavity or paranasal malignancy
Pregnancy
Already undergone prehospital nasal packing
Prisoners
Epistaxis caused by trauma (excluding simple nose picking)
Any Known bleeding disorders
Any recent use of anticoagulation drugs
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers were generated through computerized block randomization using SPSS software version 23.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, care providers, investigators, outcome assessors, and data collectors will be blinded to the topically applied medications used for stopping bleeding. Data Safety and Monitoring Board and manuscript writers will be not blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of School of Medicine - Shiraz University of Medical Sciences
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
7194646861
Approval date
2020-11-16, 1399/08/26
Ethics committee reference number
IR.SUMS.MED.REC.1399.440
Health conditions studied
1
Description of health condition studied
Epistaxis
ICD-10 code
R04.0
ICD-10 code description
Epistaxis
Primary outcomes
1
Description
Need for use of anterior nasal packing
Timepoint
at any time during that ED attendance after initial management
Method of measurement
determined by clinical judgment
Secondary outcomes
1
Description
need for use of electrical cauterization
Timepoint
at any time during ED attendance after initial intervention
Method of measurement
determined by clinical judgment of physician
2
Description
rebleeding within 24 hours after presenting to ED
Timepoint
within 24 hours after treatment
Method of measurement
self-statement of the patient with telephone call
3
Description
rebleeding within 1-7 days after presenting to ED
Timepoint
1-7 days after presenting to ED
Method of measurement
self-statement of the patient with telephone call
4
Description
ED stay more than 2 hours
Timepoint
from presenting to ED to leaving the hospital
Method of measurement
This outcome variable will be evaluated and reported as a qualitative variable. The patients who have been discharged from ED after 2 hours from the presentation will be considered as positive cases for this variable.
Intervention groups
1
Description
Intervention group: In the intervention group, medicated cotton pledgets soaked into IV formulation of tranexamic acid (tranexip, 500mg/5ml, Caspian Tamin) plus phenylephrine nasal drop (Nasopherin, 0.5%, Sina Darou) plus lidocaine solution (10%, Iran Darou) will be inserted in each nostril for 15 minutes for initial epistaxis management in the ED.
Category
Treatment - Drugs
2
Description
Control group: In the control group, medicated cotton pledgets soaked into phenylephrine nasal drop (Nasopherin, 0.5%, Sina Darou) plus lidocaine solution (10%, Iran Darou) will be inserted in each nostril for 15 minutes for initial epistaxis management in the ED.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Milad Hosseinialhashemi
Street address
Zand St.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Milad Hosseinialhashemi
Street address
Zand St
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Milad Hosseinialhashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Chamran blvd.
City
Shiraz
Province
Fars
Postal code
7194646861
Phone
+98 71 3626 7225
Email
miladhashemi88@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Milad Hosseinialhashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Chamran blvd.
City
Shiraz
Province
Fars
Postal code
7194646861
Phone
+98 71 3626 7225
Email
miladhashemi88@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Milad Hosseinialhashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Chamran blvd.
City
Shiraz
Province
Fars
Postal code
7194646861
Phone
+98 71 3626 7225
Email
miladhashemi88@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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