Investigating the effect of systemic Tranexamic Acid on the amount of bleeding in burn patients after skin excision; A randomized clinical trial

Determining the effect of systemic tranexamic acid on the amount of bleeding in the wounds of burn patients after skin removal in Shahid Madani Hospital of Alborz Province

The present study will be conducted as a random clinical trial at Shahid Madani Hospital at Alborz University of Medical Sciences in the year after receiving the ethics code and registration in the IRCT system. This study will be performed on patients between the ages of 15-55 with burn wounds undergoing surgery

The research community will include all patients with burn wounds referred to Shahid Madani Hospital at Alborz University of Medical Sciences in 1403, which will undergo skin removal surgery.

Inclusion criteria People aged 15 to 55 with deep thermal burns with dimensions greater than 20% of the total body surface Need skin removal surgery Does not require special medical services such as hospitalization in ICU Not breastfeeding or pregnant Do not have a history of hypercoagulopathy or thrombotic events Do not suffer from bleeding disorders Not associated with blunt abdominal trauma or head injury No chemical or electrical burns No 3rd degree burns Exit criteria Patients who are eligible to enter the study but did not consent to enter the study Sensitivity to tranexamic acid Systolic blood pressure higher than 200mmHg Disruption of coagulation factors Have disturbances in kidney function tests

Patients will randomly enter two groups by one to one(each group of 47) The first group or intervention group will be 1 mg/kg of the acidic acid in injection the second group or control group will receive only 1ml of normal saline

Hb amount and hematocrit before and 24 hours after surgery The amount of cell packs received between the two groups Length of stay and possible complications

For randomization, the block randomization method will be used, so that at first, blocks of four will be prepared in the Excel software as (AABB) (BBAA) (ABBA) (BAAB) (ABAB) (BABA). A will be the intervention group and B will be the control group. Then one of the blocks will be randomly selected and based on the sequence of letters in the selected block, the eligible people will be assigned to treatment groups. This random process of selecting blocks and assigning people to treatment groups will continue until the desired sample size is reached. The preparation of random allocation sequences of two intervention groups and placing them in closed (sealed) envelopes and numbering with a 5-digit serial number will be done by a third person who is not involved in the design of the study. All envelopes have a 5-digit serial number, which will be opened after recording background information, and the sample will be divided into two intervention and control groups.

Blinding: This study will be double-blind, so that the outcome evaluator and the subject will be unaware of the status of assigning people to the study groups. For the study subjects, before random allocation, it will be explained how the work process is, and they may receive one of the two treatments randomly, and the treatment to be used will not be known to the person in advance; in such a way that it will not be possible for the patient to distinguish them from each other. Therefore, the pat. For the study subjects, before random allocation, it will be explained how the work process is, and they may receive one of the two treatments randomly, and the treatment to be used will not be known to the person in advance; in such a way that it will not be possible for the patient to distinguish them from each other. Therefore, the patient will be unaware of which group he is in. Also, the outcome evaluator will not know about the status of assigning people to the study groups.ient will be unaware of which group he is in.