camparison of local Tranexamic Acid with anterior nasal packing in control of epistaxis in patients with antiplatelets therapy(ASA, Plavix) whom referring with anterior nasal bleeding.
Efficacy of topical Tranexamic Acid in control of anterior epistaxis by anterior nasal tampons is evaluated previously. This randomized,single-blind, multy-center study would be performed on patients referred to Shariati and Sina Hospitals with complaints of epistaxis from October 2015 till April 2016. Exclusion Criteria: Trauma patients; history of anticoagulants drug consumption; Inherited bleeding disorders; Hemophiliacs; Inherited platelet disorders; Shock; Lack of consent; patients with visible bleeding vessel; INR>1.5 and history of renal disease. 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:IRCT201509088872N9
Registration date:2015-09-25, 1394/07/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-25, 1394/07/03
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
Tehran University of Medical Sciences -Faculty of Medicine
Expected recruitment start date
2015-10-12, 1394/07/20
Expected recruitment end date
2016-04-01, 1395/01/13
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 with antiplatelets therapy(ASA, Plavix) whom referring with anterior nasal bleeding.
Public title
effectiveness of local Tranexamic Acid on Epistaxis Control in patients with antiplateletes therapy(ASA, plavix)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: All patients with epistaxis and history of consumption of ASA and Plavix whom referring to the emergency department. Exclusion Criteria: Trauma patients; history of anticoagulants drug consumption; Inherited bleeding disorders; Hemophiliacs; Inherited platelet disorders; Shock; Lack of consent; patients with visible bleeding vessel; history of renal disease; INR> 1.5
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics review committee of Tehran University of Medical Siences-Faculty of Medicine,Dr Akbar fotouhi
Street address
floor 5, NO 226,Poursina avenue, Ghods avenue,Enghelab square, Tehran
City
Tehran
Postal code
Approval date
2015-08-26, 1394/06/04
Ethics committee reference number
IR.TUMS.REC.1394.660
Health conditions studied
1
Description of health condition studied
Epistaxis
ICD-10 code
R04.0
ICD-10 code description
خونریزی از بینی
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
Secondary outcomes
1
Description
bleeding recurrence
Timepoint
first 24 hours and the first week
Method of measurement
measured by watch
2
Description
patient's satisfaction
Timepoint
within discharge
Method of measurement
by VAS measurment system (10 points mark)
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
Emergency Department of Sina and Shariati Hospitals
Full name of responsible person
Dr Morteza Saeedi
Street address
Sina Hospital ( Hsanabad Square)and Shariati Hospital(beside Eghtesad university; Al Ahmad high way; North Kargar avenue) Emergency Departement
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences -Faculty of Medicine
Full name of responsible person
Dr Shahin Akhundzade
Street address
Vice Chancellor for Research of Tehran ,University of Medical Sciences, Poursina Avenue, Enghelab Square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences -Faculty of Medicine
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 Department;Associate Professor of Emergency Medicine