Sixty percent of the population will experience at least once epistaxis. The most common model of the bleeding is the anterior bleeding from the nose. Systemic Acid Tranexamic is used in the control of nasal bleeding in patients with inherited telangiectasias.
Efficacy of topical Tranexamic Acid in control of anterior epistaxis by anterior nasal tampons is evaluated in this study. This randomized, double-blind, single-center study would be performed on patients referred to Imam Reza hospital with complaints of epistaxis from February 2011 till July 2012. Exclusion criteria include patients with multiple traumas, shock, lack of patient's satisfaction, and INR > 1.5. Two hundred Patients placed in each group are treated differently. In the intervention group, a 15cm-cotton wick dipped in Acid Tranexamic is used. The wick is placed in the nasal cavity and the bleeding is evaluated and recorded in 5-minute intervals. The bleeding recurred in 24 hours and one week later will be assessed. Patient’s discharge time from the emergency department is also recorded. In the second group (control group) common methods are used to control the bleeding, which are shrinkage of the anterior nasal and then placing the tampon. All variables mentioned in the first group are recorded in this group, too. If bleeding is not controlled in Acid Tranexamic group, then the common method for controlling the bleeding is used. Finally, patient’s satisfaction of treatment is evaluated using a numerical scoring system.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201308872N1
Registration date:2012-04-25, 1391/02/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-25, 1391/02/06
Registrant information
Name
Morteza Saeedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2719
Email address
m_saeedi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-01-19, 1390/10/29
Expected recruitment end date
2012-06-04, 1391/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
camparison of local Tranexamic Acid with anterior nasal packing in control of epistaxis in patients referring with anterior nasal bleeding.
Public title
effectiveness of local Tranexamic Acid on Epistaxis Control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: All patients with epistaxis referring to the emergency department. Exclusion Criteria: multiple traumas; shock; Lack of patient's satisfaction; INR> 1.5
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Daneshgah St., Tabriz, Iran
City
Tabriz
Postal code
Approval date
2012-01-18, 1390/10/28
Ethics committee reference number
8427;4;5
Health conditions studied
1
Description of health condition studied
Epistaxis
ICD-10 code
R04.0
ICD-10 code description
Haemorrhage from nose
Primary outcomes
1
Description
Bleeding control time
Timepoint
every 5 minutes from the start point until the bleeding stops
Method of measurement
measured by stopwatch, per minute
2
Description
bleeding recurrence
Timepoint
first 24 hours and the first week
Method of measurement
measured by watch
3
Description
patient's satisfaction
Timepoint
within discharge
Method of measurement
by VAS measurment system (10 points mark)
Secondary outcomes
empty
Intervention groups
1
Description
Tranexamic Acid: Ampoule, 100mg/ml, Local, the wick is soaked in 5cc of solution.
Category
Treatment - Drugs
2
Description
Epinephrine 1/100000 and Lidocine 2%, Solution, Local, the wick is soaked in 5cc of solution.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Said Alizadeh Arasi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Tabriz Medical University
Full name of responsible person
Dr Mohammadreza Rashidi
Street address
Shariati hospital, North Amir Abaad St., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Tabriz Medical University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Morteza Saeedi
Position
Emergency Medicine Specialist; Assistant Professor