Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Need for anterior nasal packing
General information
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Reason for update
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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
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Acronym
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IRCT registration information
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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
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Registration date
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2021-04-10, 1400/01/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-04-21, 1400/02/01
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Expected recruitment end date
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2021-09-21, 1400/06/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the ٍeffect of Topical Intranasal Tranexamic Acid for Stopping Nose Bleeding in Patients with Epistaxis in the ENT Emergency Department
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Public title
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Topical Intranasal Tranexamic Acid in Epistaxis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
240
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random numbers were generated through computerized block randomization using SPSS software version 23.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-11-16, 1399/08/26
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Ethics committee reference number
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IR.SUMS.MED.REC.1399.440
Health conditions studied
1
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Description of health condition studied
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Epistaxis
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ICD-10 code
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R04.0
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ICD-10 code description
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Epistaxis
Primary outcomes
1
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Description
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Need for use of anterior nasal packing
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Timepoint
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at any time during that ED attendance after initial management
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Method of measurement
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determined by clinical judgment
Secondary outcomes
1
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Description
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need for use of electrical cauterization
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Timepoint
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at any time during ED attendance after initial intervention
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Method of measurement
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determined by clinical judgment of physician
2
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Description
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rebleeding within 24 hours after presenting to ED
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Timepoint
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within 24 hours after treatment
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Method of measurement
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self-statement of the patient with telephone call
3
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Description
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rebleeding within 1-7 days after presenting to ED
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Timepoint
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1-7 days after presenting to ED
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Method of measurement
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self-statement of the patient with telephone call
4
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Description
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ED stay more than 2 hours
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Timepoint
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from presenting to ED to leaving the hospital
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Method of measurement
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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
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available