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IRCT20111219008458N2 IRCT 2021-04-13 Shahre-kord University of Medical Sciences Efficacy of Tranexamic Acid on Blood Loss During Rhinoplasty Efficacy of Tranexamic Acid on Blood Loss During Rhinoplasty 2021-05-22 anticipated 80 Complete https://irct.ir/trial/55109 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Rhinoplasty. Intervention 1: Intervention group: Patients receiving Tranexamic Acid (Tranexip, Caspian Tamin Pharmaceutical) 10mg/kg IV right before surgery, and after induction of anesthesia. Intervention 2: Control group: Patients receiving placebo (normal saline) in equal volumes with the case group. Yes - There is a plan to make this available What will be shared: Efficacy of Tranexamic Acid on bleeding during rhinoplasty When: Not decided To whom: Identified Researchers Conditions: Not specified Where to obtain: Not decided How to obtain: Not decided Comments:
public Hesam Panahi
Parastar Ave.
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3333 1471 hesam_panahi_87@yahoo.com Shahre-kord University of Medical Sciences scientific Hesam Panahi
Parastar Ave.
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3333 1471 hesam_panahi_87@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Without any systemic disease ASA I category 18 years 60 years Both Drug abuser or addict Renal or Liver failure Hemostatic disorders History of convulsion Hypersensitivity to Tranexamic Acid Pregnancy Treatment - Drugs Placebo Intervention group: Patients receiving Tranexamic Acid (Tranexip, Caspian Tamin Pharmaceutical) 10mg/kg IV right before surgery, and after induction of anesthesia Control group: Patients receiving placebo (normal saline) in equal volumes with the case group Amount of bleeding. Timepoint: Before intervention, Immediately after intervntion. Method of measurement: Hemoglobin concentration and blood volume in suction. Shahre-kord University of Medical Sciences Approved 2019-06-09 Ethics committee of Sharekord University of Medical Sciences Shahrekord University of Medical Sciences, Rahmatiye Ave., Shahrekord, Iran. Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)