Traumatic brain injury. Diffuse brain injury
Conditions
Interventions
Intervention 1: Control group: in this group, only routine and standard treatment is done. Intervention 2: Progesterone group: in addition to routine and standard treatment, progesterone dose 1 mg /kg
Placebo
Treatment - Drugs
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 ho
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
Sponsors
Kerman Neuroscience Research Center
Research Council of Kerman University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GOS (Glasgow-Outcome Scale-Extended ). Timepoint: after resuscitation, time discharge, 3 and 6 months after TBI. Method of measurement: Questionnaire.;FIM (Functional Independence Measure ). Timepoint: after resuscitation, time discharge, 3 and 6 months after TBI. Method of measurement: Questionnaire.;CRS-R ( coma recovery scale – revised ). Timepoint: After resuscitation, time discharge, 3 and 6 months after TBI. Method of measurement: Questionnaire.;Serum infammatory factors. Timepoint: After resuscitation, 24 hours and 6 days after TBI. Method of measurement: ELISA.;Serum brain proteins. Timepoint: After resuscitation, 24 hours and 6 days after TBI. Method of measurement: ELISA.;Serum MDA(Malon dialdeid ) Levels. Timepoint: After resuscitation, 24 hours and 6 days after TBI. Method of measurement: Thiobarbituric acid method.;Serum protein carbonyl content. Timepoint: After resuscitation, 24 hours and 6 days after TBI. Method of measurement: DNPH(2, 4-D Nytrvfnl hydrazine) method.;Serum levels of total antioxidant activity. Timepoint: After resuscitation, 24 hours and 6 days after TBI. Method of measurement: ferric reducing of antioxidants power (FRAP). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality. Timepoint: 24 hours, and 1, 3 and 6 months after TBI. Method of measurement: number.;Complications and adverse effects. Timepoint: 24 hours, and 1, 3 and 6 months after TBI. Method of measurement: visual.;Length of stay. Timepoint: Hospitalization time. Method of measurement: visual.;Differenace GCS between Admission and discharge times. Timepoint: hospitalization. Method of measurement: visual. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mohammad Khaksari
Kerman University of Medical Sciences
Outcome results
None listed