Severe Head Trauma
Conditions
Brief summary
To investigate the effectiveness of progesterone as a neuroprotective in patients severe traumatic brain injury in clinical outcome
Interventions
DRUGProgesterone
Hormonal treatment
DRUGThe usual head trauma care
the basic treatment
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Intramuscular injection of progesterone
Eligibility
Sex/Gender
ALL
Age
16 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
patients with severe traumatic head injury GCS ≤8 both sexes. \>16yrs, \-
Exclusion criteria
* -Tumor that may flare with progesterone. * patients with spinal injuries with neurological deficits. * severe chest trauma that causes shock and hypoxia. * life-threatening systemic injuries that cause hemodynamic instability, cardiac arrest * pegnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glasgow outcome scale GOS-E score | 1year | as thhe following:1-indicates death 2-indicates a vegetative state, 3 or 4 indicates a severe disability, 5 or 6 indicates a moderate disability and 7 or 8 indicates a good recovery. (8, 9) |
| FIM score | 1 year | is available measure of dependence in two subscales (motor and cognitive) (10) . Motor domains self care (eating, grooming, bathing, body upper dressing, body lower dressing, swallowing, moving to bed and chair, toileting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilator | 1month | Duration of mechanical ventilator |
| mortality rate | 1 month | death rate at 1 month |
| Gcs | 1 year | Gcs |
| adverse events | 1 month | adverse events |
| Duration of hospital stay | 1month | Duration of hospital stay |
Contacts
Primary ContactIslam Abd El Aal Helmy
Outcome results
None listed