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General information
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 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.
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
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
با توجه به اینکه رجیستری کارآزمایی بالینی زودتر از زمان پیش بینی شده ی محققین انجام شد، مطالعه از یک اردیبهشت 1400 شروع خواهد شد. هم چنین به دلیل شلوغی اورژانس امکان ارزیابی دقیق زمان توقف خون ریزی نمی باشد لذا این پیامد ارزیابی نخواهد شد. طبق نظر محققین، مطالعه از یک سو کور به دو سو کور تغییر خواهد کرد.
با توجه به اینکه رجیستری کارآزمایی بالینی زودتر از زمان پیش بینی شده ی محققین انجام شد، مطالعه از یک اردیبهشت 1400 شروع خواهد شد. هم چنین به دلیل شلوغی اورژانس امکان ارزیابی دقیق زمان توقف خون ریزی نمی باشد لذا این پیامد ارزیابی نخواهد شد. طبق نظر محققین، مطالعه از یک سو کور به دو سو کور تغییر خواهد کرد. هم چنین مصرف اخیر هر گونه داروی ضد انعقادی به عنوان معیار های خروج از مطالعه اضافه خواهد شد.
با توجه به اینکه رجیستری کارآزمایی بالینی زودتر از زمان پیش بینی شده ی محققین انجام شد، مطالعه از یک اردیبهشت 1400 شروع خواهد شد. هم چنین به دلیل شلوغی اورژانس امکان ارزیابی دقیق زمان توقف خون ریزی نمی باشد لذا این پیامد ارزیابی نخواهد شد. طبق نظر محققین، مطالعه از یک سو کور به دو سو کور تغییر خواهد کرد. هم چنین مصرف اخیر هر گونه داروی ضد انعقادی به عنوان معیار های خروج از مطالعه اضافه خواهد شد.
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
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
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
نا پایداری همودینامیک
آلرژی شناخته شده به ترانگزامیک اسید
عدم توانایی یا تمایل به دادن رضایت
بدخیمی شناخته شده ی نازوفارنژیال، حفره بینی یا پارانازال
بارداری
پک بینی قبل از مراجعه به بیمارستان
زندانی ها
خون ریزی از بینی به دلیل تروما (به جز مواردی که در اثر دستکاری ساده بینی ایجاد شده باشد.)
هر گونه بیماری شناخته شده ی خون ریزی دهنده
نا پایداری همودینامیک
آلرژی شناخته شده به ترانگزامیک اسید
عدم توانایی یا تمایل به دادن رضایت
بدخیمی شناخته شده ی نازوفارنژیال، حفره بینی یا پارانازال
بارداری
پک بینی قبل از مراجعه به بیمارستان
زندانی ها
خون ریزی از بینی به دلیل تروما (به جز مواردی که در اثر دستکاری ساده بینی ایجاد شده باشد.)
هر گونه بیماری شناخته شده ی خون ریزی دهنده
هر گونه مصرف اخیر داروهای ضد انعقادی
نا پایداری همودینامیک آلرژی شناخته شده به ترانگزامیک اسید عدم توانایی یا تمایل به دادن رضایت بدخیمی شناخته شده ی نازوفارنژیال، حفره بینی یا پارانازال بارداری پک بینی قبل از مراجعه به بیمارستان زندانی ها خون ریزی از بینی به دلیل تروما (به جز مواردی که در اثر دستکاری ساده بینی ایجاد شده باشد.) هر گونه بیماری شناخته شده ی خون ریزی دهنده هر گونه مصرف اخیر داروهای ضد انعقادی
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:2021-08-15, 1400/05/24
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
need for blood transfusion or surgical intervention
Timepoint
at any time during ED attendance after initial intervention
Method of measurement
determined by clinical judgment of physician
3
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
4
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
5
Description
duration of ED stay
Timepoint
from presenting to ED to leaving the hospital
Method of measurement
clock (hours)
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