Evaluation of the effect of intravenous tranexamic acid on bleeding during burn surgery: a double blinded clinical trial

Our aim was to investigate and measure the effect of intravenous injection of tranexamic acid on bleeding during burn surgery in patients with severe burns during a double-blind clinical trial.

A clinical trial with parallel, double-blind groups, randomized, phase 4 on 82 patients. For randomization, the Rnnif command of software R is used.

In a burn OR, severe burn patients receive tranexamic acid and a placebo solution in separate groups before anesthesia. The volume of bleeding is calculated by hemoglobin before and after surgery, volume of bleeding, and transfusion. Burn surgeon, patients, and the resident in charge of data registration are blinded to the trial.

Inclusion criteria: 18-50 years, severe burns, and candidates for burn surgery. Exclusion Criteria: history of cardiovascular disease, liver or kidney damage, pregnancy or lactation, ophthalmic pathologies, different coagulopathies, or history of allergy to tranexamic acid, drug side effects such as seizures and vascular thromboembolic events.

In the α group (standard treatment) before induction of anesthesia, 10mg/kg of normal saline solution will be infused into the patient Intravenously and continued every hour during surgery. The above is to protect the blinding. In the β group (receiving 10mg/kg Tranexamic acid) before induction of anesthesia, 10mg/kg of Tranexamic solution in normal saline serum will be infused for 5 minutes. 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.

The volume of bleeding during surgery: blood in the suction device, the number of blood gases, the amount of blood in the field of surgery, the Gross formula.

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.

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.