The aim of this study is to evaluate the effectiveness of tranexamic acid in intraoperative bleeding and post operative edema and echymosis This study is a double-blinded clinical trial on 60 rhinoplasty candidates with no systemic problem. The subjects will be randomly divided into two groups. The first group (control) will receive routine treatment. In the second group (target group) in addition to routine treatment ,10 mg/kg tranexamic acid intravenously just before surgery will be administered.
The amount of bleeding during the surgery will be measured by suctioned fluids, bloody and dry gas weight difference. Eyelid edema and ecchymosis around the eyes will be measured using standard scoring tools 24 hours after surgery by an observer. The results obtained will be statistically analyzed and the significance will be examined to determine the effect of tranexamic acid.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071013938N1
Registration date:2014-07-12, 1393/04/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-12, 1393/04/21
Registrant information
Name
Mohamadali Ghavimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5968
Email address
ghavimim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-08-22, 1392/05/31
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of Tranexamic acid in intervention and placebo groups in rhinoplasty patients
Public title
The effect of Tranexamic acid in bleeding and echymosis in corrective nose surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Healthy Men and Female; Age range between 19- 39.
Exclusion criteria: Men and Female between 19- 39 years old with Systemic and Methabolic diseases.
Age
From 19 years old to 39 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
Central Bulding of Tabriz University of Medical Sciences, Golgasht st, Azadi ave
City
Tabariz
Postal code
Approval date
2014-05-26, 1393/03/05
Ethics committee reference number
9332
Health conditions studied
1
Description of health condition studied
Bleeding ,Oedema and Echymosis
ICD-10 code
Y40,Y84
ICD-10 code description
Anaesthetics and therapeutic gases
Primary outcomes
1
Description
Bleeding
Timepoint
Just after intervention
Method of measurement
x=volum of suction+ (weight of bloody guazes - weight of dry guazes) total bleeding=x-volum of irigation fluides uses in surgery
Secondary outcomes
1
Description
Oedema
Timepoint
24 hours after surgery
Method of measurement
Standarad 4 scale system
2
Description
Echymosis
Timepoint
24 hours after surgery
Method of measurement
Standarad 4 scale system
Intervention groups
1
Description
IV adminstration of 10 mg/kg tranexamic acid just befor begining of surgery
Category
Treatment - Drugs
2
Description
20 ml normal saline IV injection as placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamreza hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.farhoodi
Street address
Building no 2, Tabriz Univercity of Medical Sciences, Golgasht st
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Ghavimi
Position
Assistant Professor of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Oral and Maxillofacial Department, Second floor, Ememreza Hospital
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
ghavimim@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Ali Ghavimi
Position
Assistant Professor of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Oral and Maxillofacial Department, Second floor, Ememreza Hospital
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
ghavimim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Miramir Chavoshzadeh
Position
Dentistry student
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
Fax
Email
amir_ch2002ir@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)