Evaluation of the therapeutic effect of topical tranexamic acid in control of epistaxis of nasal bleeding
Design
A clinical trial with 162 sample size with a control group, with parallel, double-blinded, randomized groups
Settings and conduct
The study population consisted of all epistaxis patients referred to the emergency department of Alzahra and Kashani hospitals in Isfahan. These were randomly selected. Demographic and clinical data including age, gender, history of cardiovascular disease, history of nasal bleeding, systolic and diastolic blood pressure and mean arterial and heart rate were recorded. Patients were divided into 4 groups. After intervention in each group, patients remained in the emergency department for up to 30 minutes and were evaluated every 5 minutes for recording bleeding time. The criteria for cessation of bleeding are, according to your physician, the absence of any bleeding. In addition, the patient's status was monitored by telephone over the first 24 hours and the first week after intervention and side effects such as nausea and vomiting until one week after hospital discharge. Patient satisfaction level was also scored based on a score of 0 to 3.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Anterior epistaxis with idiopathic etiology; Exclusion criteria: Posterior epistaxis; A history of bleeding disorders such as thrombocytopenia, hemophilia and platelet disorders; Seizure; Arterial or intravenous thrombosis;
Intervention groups
We have three intervention groups. In the first group as control group, patients were treated with tampon.
The second group of tranexamic acid is injected into the bleeding nasal canal. And the third group uses in addition to tranexamic acid injectable tampon, which is fatty tetracycline ointment.
Main outcome variables
Stop the bleeding, Rebleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160130026253N3
Registration date:2020-01-16, 1398/10/26
Registration timing:registered_while_recruiting
Last update:2020-01-16, 1398/10/26
Update count:0
Registration date
2020-01-16, 1398/10/26
Registrant information
Name
Alireza Abootalebi Ghahnavieh
Name of organization / entity
Isfahan University of medical sciences, Emergency Department, Isfahan, I. R, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2085
Email address
a_abootalebi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Isfahan University of Medical Sciences
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of topical tranexamic versus nasal tampon in epistaxis in patient who admit to Alzahra anh Kashani Hospital of Isfahan
Public title
Comparison of topical tranexamic versus nasal tampon in epistaxis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients with unilateral idiopathic anterior epistaxis
Exclusion criteria:
Posterior epistaxis
A history of bleeding disorders such as thrombocytopenia, hemophilia and platelet disorders
Seizure
Arterial or intravenous thrombosis
Use of anticoagulants, platelets and aspirin
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
162
Randomization (investigator's opinion)
Randomized
Randomization description
The study sample was randomly divided into three groups each by selective envelopes. Thus, each envelope containing one of the three A, B, C labels represented one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs were placed in closed envelopes coded A and B and C without labeling and without the knowledge of the investigator.Patients and investigator were unaware of the kind of treatment in each envelope.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjirib St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-01-25, 1394/11/05
Ethics committee reference number
IR.MUI.REC.1394.3.880
Health conditions studied
1
Description of health condition studied
Epistaxis
ICD-10 code
R04.0
ICD-10 code description
Epistaxis
Primary outcomes
1
Description
Stop the bleeding
Timepoint
Every 5 minutes
Method of measurement
stopwatch
2
Description
Rate of rebleeding
Timepoint
During the first 24 hours as well as the first week after intervention
Method of measurement
stopwatch
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group 15 cm gas was immersed in tranexamic acid at a concentration of 500 mg / ml in 5 ml and placed in the bleeding nasal duct.
Category
Treatment - Drugs
2
Description
Control group: Patients were treated with tamponine, which was oily tetracycline ointment and remained in the nasal duct for 3 days.
Category
Treatment - Devices
3
Description
Intervention second group: In this group, 15 cm gas was immersed in tranexamic acid at a concentration of 500 mg / ml and placed in the bleeding nasal duct. It was placed in the nasal canal for 3 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Department of Isfahan Alzahra
Full name of responsible person
Alireza Abootalebi Ghahnavieh
Street address
Sofe Blvd, Isfahan Province, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8164733734
Phone
+98 31 3661 9729
Email
A_abootalebi@yahoo.com
2
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Alireza Abootalebi Ghahnavieh
Street address
Kashani St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3661 9729
Email
A_abootalebi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
A_abootalebi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Isfahan University of medical sciences, Emergency Department, Isfahan, I. R, Iran
Full name of responsible person
Alireza Abootalebi Ghahnavieh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Street address
no.125 Ahmadi Alley. North Sheikhsadogh St.
City
Isfahan
Province
Isfehan
Postal code
8164733734
Phone
+98 31 3620 2085
Fax
Email
a_abootalebi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of medical sciences, Emergency Department, Isfahan, I. R, Iran.
Full name of responsible person
Alireza Abootalebi Ghahnavieh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Al-Zahra Hospital, Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
8164733734
Phone
+98 31 3620 2085
Fax
Email
a_abootalebi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of medical sciences, Emergency Department, Isfahan, I. R, Iran.
Full name of responsible person
Alireza Abootalebi Ghahnavieh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Street address
No.125, Ahmadi Alley, North Sheykh Sadough, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8164733734
Phone
+98 31 3661 9729
Fax
Email
A_abootalebi@yahoo.com
Web page address
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
No - There is not 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Email: A_abootalebi@yahoo.com
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.