Comparison of the effect of local and intravenous Tranexamic Acid and Phenylephrine Shrink on control of bleeding in patients with epistaxis: a double-blind randomized clinical trial
To compare the effect of local and intravenous Tranexamic Acid and Phenylephrine Shrink on control of bleeding in patients with epistaxis
Design
This is a double-blind randomized clinical trial, phase II, in which 90 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with epistaxis who will refer to Besat Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 70 years;
Epistaxis
Exclusion criteria:
Hypertension;
Contraindication of Phenylephrine;
A history of coagulopathy;
A history of nasal surgery
Intervention groups
Intervention group 1: Injection of Tranexamic Acid 1 gr single dose
Intervention group 2: Use of local tampon stained with Tranexamic Acid 500 mg once
Intervention group 3: Use of Phenylephrine Shrink drops 0.5% once
Main outcome variables
Assessing the bleeding rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N244
Registration date:2018-10-20, 1397/07/28
Registration timing:prospective
Last update:2018-10-20, 1397/07/28
Update count:0
Registration date
2018-10-20, 1397/07/28
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of local and intravenous Tranexamic Acid and Phenylephrine Shrink on control of bleeding in patients with epistaxis: a double-blind randomized clinical trial
Public title
Comparison of the effect of local and intravenous Tranexamic Acid and Phenylephrine Shrink on control of bleeding in patients with epistaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 70 years;
Epistaxis
Exclusion criteria:
Hypertension;
Contraindication of Phenylephrine;
A history of coagulopathy;
A history of nasal surgery
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on every two sheets the name of each treatment. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be unaware of the type of intervention. In addition, the physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.UMSHA.REC.1397.417
Health conditions studied
1
Description of health condition studied
Epistaxis
ICD-10 code
R04.0
ICD-10 code description
Epistaxis
Primary outcomes
1
Description
Assessing the bleeding rate
Timepoint
5 and 10 minutes after intervention
Method of measurement
By physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Injection of Tranexamic Acid 1 gr single dose
Category
Treatment - Drugs
2
Description
Intervention group 2: Use of local tampon stained with Tranexamic Acid 500 mg once
Category
Treatment - Drugs
3
Description
Intervention group 3: Use of Phenylephrine Shrink drops 0.5% once
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Sadegh Chaeichi
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
sadeghchaeichi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Sadegh Chaeichi
Position
Emergency Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
sadeghchaeichi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Rasoul Salimi
Position
Emergency Medicine Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
rasoulsl@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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