Health Condition 1: null- Severe Traumatic Brain Injury
Conditions
Interventions
Intervention1: Progesterone Injection: 1.0 mg/kg via intramuscular injection and then once every 12 hours for 5 consecutive days.
Control Intervention1: distilled water: 1.0 mg/kg via intramuscular in
Sponsors
DEPARTMENT OF BIOTECHNOLOGY
Eligibility
Inclusion criteria
Inclusion criteria: i.Male or female patients between the ages of 18 and 65 years with suspected TBI ii.Glasgow Coma Scale (GCS) score 4-8 after resuscitation and stabilization iii.Patients who arrived within 8 hrs of injury
Exclusion criteria
Exclusion criteria: i.Patients who had received any investigational drugs 30 days prior to the enrollment, such as progesterone, estrogen and any other investigational compound ii.Patients with severe anoxic intracerebral damage or brain death iii.Patients whose clinical condition is unstable (partial pressure of oxygen 60 mmHg or a systolic blood pressure 90 mmHg, or both) iv.Pregnant or lactating female patients v.Doubt whether the altered neurological status resulted from head trauma or acute or chronic spinal cord injury.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Glasgow Outcome Scale (GOS) score Timepoint: at 1 month, at 3 months and at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functional Independence Measure (FIM) score 2. mortalityTimepoint: at 1 month, at 3 months and at 6 months | — |
Countries
India
Contacts
Public ContactSumit Sinha
All India Institute of Medical Sciences, New Delhi, India
Outcome results
None listed