Evaluating the effect of Tranexamic acid on brain contusion and intracerebral hemorrhage in patients with traumatic brain injury (TBI)

Evaluating the effect of Tranexamic acid on brain contusion and intracerebral hemorrhage in patients with traumatic brain injury (TBI)

A clinical trial with the control group, with parallel groups, double-blind, randomized, phase 3 on 80 patients

This study is a randomized clinical trial that will be performed in Kashan's Shahid Beheshti Hospital. 40 patients in each group, receiving tranexamic acid and control, will be evaluated. In order to blind the study, syringes containing tranexamic acid and normal saline, will be drawn, coded by one of the colleagues and provided to the nurses of the relevant wards to inject into the patients under study, based on random blocking. None of the physicians or nurses were aware of the type of medication used for the patients

Inclusion criteria: All patients over 13 years of age with blunt traumatic brain injury referred to the emergency department who have been less than 3 hours from the time of the accident to the arrival and have cerebral hemorrhage on CT scan. Exclusion criteria: Major organ damage requiring surgical intervention during the first 3 hours, Taking any medication that interferes with homeostasis.

Intervention group: Tranexamic acid drug, produced by Iran Daroo company, IR Iran, is infused with the initial dose of 1 g per 100 ml of serum within 10 minutes and then with a dose of 1 g per 1000 ml of serum for 8 hours, as maintenance dose. Control group: Placebo, containing normal saline serum produced by Iran Daroo Co, IR Iran, is infused with an initial dose of 1 gr in 100 cc normal saline in 10 minutes and continued with dose of 1 gr in 1000 cc in 8 hours as maintenance dose.

Brain contusion and intracerebral hemorrhage

Random allocation of patients (randomization unit is "person") into two groups of 40 people was performed using a random quadruple block method, that is done through the website: www.sealedenvelope.com. In each of the 20 quadruple blocks, 2 patients will receive medication (tranexamic acid) and 2 patients will receive placebo (normal saline). It should be noted that this study is a three-blind study in which physicians and nurses, patients and analyst will be unaware of patient groups.

In order to blind the study, syringes containing tranexamic acid and normal saline were pre-drawn, coded, and delivered to the nurses of the relevant wards to inject into the patients under study based on random blocking. None of the physicians and nurses knew the type of medication used for the patients and only one of the implementers of the project knew the medication's code, so that in case of any problem or complication for the patients, he/she would break the medication's code and inform the relevant physician.

Part of the data can be shared.

The data will be available, three months after the publication.

Academic researchers, physicians, and medical students, and treatment staff personnel

Use to improve the treatment process of patients and to plan the same projects

Dr.Esmaeel Fakharian Neurosurgery ward, Shahid Beheshti Hospital, Qotbe ravandi BLVD, Kashan Tel: 00983155540026 efakharian@gmail.com

The request will be sent by email, after survey.