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IRCT20210524051384N8 IRCT 2022-10-25 Rasht University of Medical Sciences Tranexamic Acid in bleeding during burn surgery TXA Evaluation of the effect of intravenous tranexamic acid on bleeding during burn surgery: a double blinded clinical trial 2022-11-22 anticipated 82 Complete https://irct.ir/trial/66298 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, in order to allocate patients to intervention and control groups, a randomization method limited by the block randomization method will be used. Blocking is usually used to balance the number of samples assigned to each of the studied groups. This feature helps the researcher to equal the number of samples assigned to each of the studied groups in cases where intermediate analysis is required during the sampling process. In this study, by equal to the size of blocks, blocks with size 6 (three participants in the intervention group and three participants in the control group) will be used, Blinding description: Patients who have entry criteria and do not have non-entry criteria will be included in the study after obtaining informed consent. The file number and specifications of each patient will be recorded in predetermined forms. Then, according to the file number and using computer software, they enter one of the two groups of α and β group. This division is carried out by the statistician and the results are provided to the medical records officer of the operating room in closed envelopes. Then, based on the file number in each envelope and the clinical trial code allocated, that person will be a candidate for Tranexamic Acid or standard treatment. The surgeon (responsible for the implementation of burn surgery), the operating room assistant (responsible for recording patient information in predetermined lists), the head of the medical records unit of the operating room, the patient, the anesthesiologist, and the anesthesiologist are not informed of the contents of the envelope and the type of treatment of each patient. 4 Burn Injury. Intervention 1: Severe burn patients with good hemodynamic status enter the operating room and undergo anesthesia. In the β group (receiving 10mg/kg tranexamic acid infusion before surgery) before induction of anesthesia, 10mg/kg of tranexamic acid solution in normal saline serum will be infused for 5 minutes. Then, the patient will be anesthetized under the supervision of an anesthesiologist. Then, from the onset of surgery to the end of the surgery, 1mg/kg of the same substance will be infused into the serum every hour. Hemodynamic status and bleeding rate are calculated. Necessary support is induced for the hemodynamic balance of patients. At the same time, drug and placebo infusion continues during surgery. At the end of the surgery, the mentioned items are set up by an anesthesiologist and burn specialist in a questionnaire and the patient is transferred to recovery. In the recovery section, a blood sample is taken to measure the amount of hemoglobin, hematocrit, and coagulation profile. Intervention 2: Control group: Severe burn patients with good hemodynamic status enter the operating room and undergo anesthesia.In the alpha group (receiving 10mg/kg saline infusion before surgery) before induction of anesthesia, 10mg/kg of normal saline serum will be infused for 5 minutes. Then, the patient will be anesthetized under the supervision of an anesthesiologist. Then, from the onset of surgery to the end of the surgery, 1mg/kg of the same substance will be infused into the serum every hour(for the sake of blinding process). Hemodynamic status and bleeding rate are calculated. Necessary support is induced for the hemodynamic balance of patients. At the same time, drug and placebo infusion continues during surgery. At the end of the surgery, the mentioned items are set up by an anesthesiologist and burn specialist in a questionnaire and the patient is transferred to recovery. In the recovery section, a blood sample is taken to measure the amount of hemoglobin, hematocrit, and coagulation profile. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is no further information is available
public mohammadreza mobayen
Namjo St, Velayat Hospital
rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 maziar.mobayen@gmail.com Rasht University of Medical Sciences scientific mohammadreza mobayen
Namjoo
rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 maziar.mobayen@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) patients age between 18 and 50 severe burn (TBSA>20%) candidate for burn surgery 18 years 50 years Both history of cardiovascular disease Liver or kidney injury pregnancy or lactating occular pathologies different coagulopathies history of allergy to Tranexamic acid خونریزی از T81.0 Treatment - Drugs Treatment - Drugs Severe burn patients with good hemodynamic status enter the operating room and undergo anesthesia. In the β group (receiving 10mg/kg tranexamic acid infusion before surgery) before induction of anesthesia, 10mg/kg of tranexamic acid solution in normal saline serum will be infused for 5 minutes. Then, the patient will be anesthetized under the supervision of an anesthesiologist. Then, from the onset of surgery to the end of the surgery, 1mg/kg of the same substance will be infused into the serum every hour. Hemodynamic status and bleeding rate are calculated. Necessary support is induced for the hemodynamic balance of patients. At the same time, drug and placebo infusion continues during surgery. At the end of the surgery, the mentioned items are set up by an anesthesiologist and burn specialist in a questionnaire and the patient is transferred to recovery. In the recovery section, a blood sample is taken to measure the amount of hemoglobin, hematocrit, and coagulation profile. Control group: Severe burn patients with good hemodynamic status enter the operating room and undergo anesthesia.In the alpha group (receiving 10mg/kg saline infusion before surgery) before induction of anesthesia, 10mg/kg of normal saline serum will be infused for 5 minutes. Then, the patient will be anesthetized under the supervision of an anesthesiologist. Then, from the onset of surgery to the end of the surgery, 1mg/kg of the same substance will be infused into the serum every hour(for the sake of blinding process). Hemodynamic status and bleeding rate are calculated. Necessary support is induced for the hemodynamic balance of patients. At the same time, drug and placebo infusion continues during surgery. At the end of the surgery, the mentioned items are set up by an anesthesiologist and burn specialist in a questionnaire and the patient is transferred to recovery. In the recovery section, a blood sample is taken to measure the amount of hemoglobin, hematocrit, and coagulation profile. Bleeding volume during burn surgery. Timepoint: During surgery. Method of measurement: 1. Blood in the suction machine.2. For each simple surgical gas that is completely impregnated with blood, 20 cc and 40 cc of bleeding will be calculated for each longaze that is completely impregnated with blood.3. The amount of bleeding in the field of surgery: This amount will be expressed according to the estimates of the surgeon and anesthesiologist. In the ninth edition of the Burn Overall Care Book published in 2018, Herndon et al. presented an improved version of the Gross formula first used in 1983, in which the rate of in-operation bleeding is calculated in three main sections. In the first section, the expected blood volume in the patient is calculated. The second section is the fraction of lost blood, which is calculated based on hematocrit before and after surgery. The third section is the amount of volume transferred to the patient during surgery to consider the effects of fluid therapy and its progress effects during surgery on the amount of bleeding. It should be noted that since there is no physician's opinion and the results are expressed subjectively, it will have the lowest bias. Therefore, the main primary outcome in this study is the result of the above formula in CC. Blood transfusion. Timepoint: during and in the 24hours of surgery. Method of measurement: packed cells received. Rasht University of Medical Sciences Approved 2022-08-17 Ethics committee of Guilan University of Medical Sciences Burn and Regerenative Medicine Research Center, Poursina four-way, Namjoo Street, Rasht, Guilan Rasht Guilan Iran (Islamic Republic of)