Investigation the effect of tranexamic acid on reduction of edema and ecchymosis in patients undergoing rhinoplasty
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 120 patients candidate for rhinoplasty.
Settings and conduct
This study will be conducted with the aim of investigation the effect of tranexamic acid on edema and ecchymosis reduction in 120 patients candidate for rhinoplasty. After inclusion in the study, using block randomization with quadrilateral blocks method the patients will be assigned into two groups; tranexamic acid group receiving 1000 mg tranexamic acid 2 hours before operation and 1000 mg every 8 hours after operation for 3 times and control group receiving placebo. Finally, 3, 5, 7 and 10 days after surgery the edema and ecchymosis will be measured using 0-4 Point scoring tool and will be compared together.
Participants/Inclusion and exclusion criteria
Inclusion criterion: patients candidate for rhinoplasty
Exclusion criteria:Allergy to tranexamic acid, having coagulation disorders, having a history of gastric ulcer or bleeding
Intervention groups
Intervention group: Receiving 1000 mg tranexamic acid 2 hours before operation and 1000 mg every 8 hours after operation for 3 times
Control group: Receiving tranexamic acid placebo 2 hours before operation and every 8 hours after operation for 3 times
Main outcome variables
Edema
Ecchymosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200112046095N1
Registration date:2020-05-30, 1399/03/10
Registration timing:registered_while_recruiting
Last update:2020-05-30, 1399/03/10
Update count:0
Registration date
2020-05-30, 1399/03/10
Registrant information
Name
Hanie Samareh khammar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3348 9551
Email address
hani.samareh@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of tranexamic acid on reduction of edema and ecchymosis in patients undergoing rhinoplasty
Public title
The effect of tranexamic acid on reduction of edema and ecchymosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for rhinoplasty
Exclusion criteria:
Allergy to tranexamic acid
Having coagulation disorders
Having a history of gastric ulcer or bleeding
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of 10. The patients will be randomly assigned into 2 groups of 60. Considering the sample size of 120 ( 60 patients in tranexamic acid group and 60 patients in placebo group) , 12 blocks with 10 people will be selected; in each block there will be 5 cards of each group. So by selecting each block, 5 people will be assigned into each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Tranexamic acid drugs and placebo boxes have a similar appearance so the patients are blinded ( When giving a written consent, it will be explained to the patients that for improving the accuracy of the results, the patients should be blinded but they are either in tranexamic acid or placebo group. The cons and pros of each treatment option will be explained). Assignment of the patients into two groups will be done by the student (researcher) and the surgeon who will also evaluate the patients after surgery for the edema and ecchymosis won't be aware of the assignment so he is blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Approval date
2018-04-29, 1397/02/09
Ethics committee reference number
IR.ZAUMS.REC.1397.065
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
Z41
ICD-10 code description
Encounter for procedures for purposes other than remedying health state
Primary outcomes
1
Description
Edema
Timepoint
On post-operative days 3, 5, 7 and 10
Method of measurement
0-4 Point scoring tool
2
Description
Ecchymosis
Timepoint
On post-operative days 3, 5, 7 and 10
Method of measurement
0-4 Point scoring tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving 1000 mg tranexamic acid 2 hours before operation and 1000 mg every 8 hours after operation for 3 times
Category
Prevention
2
Description
Control group: Receiving tranexamic acid placebo 2 hours before operation and every 8 hours after operation for 3 times
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al Anbiya Hospital
Full name of responsible person
Hanie Samare Khammar
Street address
Khatam al Anbiya Hospital, Jame Jam Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
hani.samareh@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
Dr.Taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Hanie Samareh khammar
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Khatam al Anbiya Hospital, Jame Jam Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3348 9551
Fax
Email
hani.samareh@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hanie Samareh khammar
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Khatam al Anbiya Hospital, Jame Jam Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3348 9551
Fax
Email
hani.samareh@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hanie Samareh khammar
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Khatam al Anbiya Hospital, Jame Jam Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3348 9551
Fax
Email
hani.samareh@zaums.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available