Traumatic brain injury is an important public health problem and a leading cause of injury -related death and disability. Inflammatory and anti- apoptotic effects and significantly reduces secondary damage. Although pre-clinical studies show the advantage of progesterone, and there are positive results two human clinical trials, more clinical trials are needed to confirm the use of progesterone in acute traumatic brain injury. Taken the neuroprotective potential benefits of estrogen therapy, time is for controlled clinical trials of estrogen therapy in traumatic brain injury. Therefore, in this study, the probable efficacy and potential mechanism of estrogen and progesterone in reduction of brain damage in patients with moderate and severe traumatic brain injury, 18 to 60 years old admitted in Kerman Shahid Bahonar Hospital, in a Randomized, double-blind, placebo- controlled clinical trial are tested .
In this study inclusion criteria: diffuse TBI; being male; having age between 18 to 60 years of age and severity of moderate to severe brain injury with GCS (Glasgow Coma Scale) (with grades 3-8 as severe and 9-12 as moderate). Exclusion criteria: patients with blunt head trauma; damage with unknown time; entering the hospital with damage time more than 4 hours; severe hypothermia (temperature less than 28 ° C); age less than 18 years and more than 60 years; SCI, patients who are candidates for craniotomy; diseases related to the immune system, gastrointestinal, oncology, infectious diseases, and other associated trauma are.
Patients are divided randomly 3 groups;
Control group: in this group, only routine and standard treatment is done.
Progesterone group: in addition to routine and standard treatment, progesterone dose 1 mg /kg within 4 hours of brain damage is administered intramuscularly, and then this dose is repeated every 12 hours for 5 consecutive days.
Estrogen group: in addition to routine and standard treatment, estrogen dose 1/25 mg within 4 hours of brain damage is administered oral, and then this dose is repeated everyday for 5 consecutive days.
In this study, GOS (Glasgow-Outcome Scale-Extended), FIM (Functional Independence Measure), and CRS-R (coma recovery scale – revised) are measured after resuscitation, time discharge, 3 and 6 months after TBI. Serum inflammatory factors, Serum brain proteins, Serum MDA (Malone dialdeid ) Levels, Serum protein carbonyl content, and Serum levels of total antioxidant activity are measured, After resuscitation, 24 hours and 6 days after TBI.