18- to 60-year-old healthy patients candidate for rhinoplasty
Intervention groups
Administration of Tranexamic Acid in intervention group, Administration of Placebo in control group
Main outcome variables
Hemoglobin concentration/Blood volume in suction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111219008458N2
Registration date:2021-04-13, 1400/01/24
Registration timing:prospective
Last update:2021-04-13, 1400/01/24
Update count:0
Registration date
2021-04-13, 1400/01/24
Registrant information
Name
Sanaz Ziaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3663 0106
Email address
ziaei@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Tranexamic Acid on Blood Loss During Rhinoplasty
Public title
Efficacy of Tranexamic Acid on Blood Loss During Rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Without any systemic disease
ASA I category
Exclusion criteria:
Drug abuser or addict
Renal or Liver failure
Hemostatic disorders
History of convulsion
Hypersensitivity to Tranexamic Acid
Pregnancy
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using google's online coin flipper. First, each group will be assigned to a coin flip result. Thereafter, a coin flip will be performed using google's online coin flipper, for each individual, and it will be decided wether the participant is in the Case or Control group. This process will be performed by one of the health care providers before the surgery.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will not know whether they participate in the Case or Control group. Apart from being informed about their participation in a clinical trial, they will receive no further information on the details of the interventions and also, they will be unconscious at the time of the random allocations. Inevitably, some healthcare providers will be informed of the details of the interventions, however, they will be instructed not to give out these information to any other person, except the data gatherer after gathering all of the data, or in case of a possible related emergency. It is worth to mention that the surgeon and the researchers will not be aware of the contents of the administered syringes. The Data Safety and Monitoring Board will only be informed of these details in case of a possible related necessity. The data gatherer will not be informed wether each patient is in the Case or Control group, until after the gathering of all the data. Thereafter, the data gatherer will be informed with the details of the interventions, and will enter all of the gathered information in the SPSS software. Participants will then be assigned with identifiers, generated with an online number generator software (numbergenerator.org). Therefor, the principle investigator, outcome assessors, and the manuscript writers will be blind to the identity of participants in both Case and Control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sharekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Rahmatiye Ave., Shahrekord, Iran.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Approval date
2019-06-09, 1398/03/19
Ethics committee reference number
IR.SKUMS.REC.1398.079
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Amount of bleeding
Timepoint
Before intervention, Immediately after intervntion
Method of measurement
Hemoglobin concentration and blood volume in suction
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receiving Tranexamic Acid (Tranexip, Caspian Tamin Pharmaceutical) 10mg/kg IV right before surgery, and after induction of anesthesia
Category
Treatment - Drugs
2
Description
Control group: Patients receiving placebo (normal saline) in equal volumes with the case group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Hesam Panahi
Street address
Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3226 4843
Email
Hesam_panahi_87@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Lotfollah Afzali
Street address
Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 1471
Email
hesam_panahi_87@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Hesam Panahi
Position
Resident Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 1471
Email
hesam_panahi_87@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hesam Panahi
Position
Resident Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 1471
Email
hesam_panahi_87@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hesam Panahi
Position
Resident Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 1471
Email
hesam_panahi_87@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Efficacy of Tranexamic Acid on bleeding during rhinoplasty
When the data will become available and for how long
Not decided
To whom data/document is available
Identified Researchers
Under which criteria data/document could be used
Not specified
From where data/document is obtainable
Not decided
What processes are involved for a request to access data/document