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To investigate the effectiveness of progesterone as a neuroprotective in patients severe traumatic brain injury in clinical outcome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with main lines of management without progesterone | Placebo Comparator | patients with main lines of management without progesterone |
|
| Patients taking progesterone plus the main lines of management of traumatic brain injury | Active Comparator | taking progesterone IM 1mg/kg twice for 5 days plus the main lines of management of traumatic brain injury |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug | Hormonal treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow outcome scale GOS-E score | 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) | 1year |
| FIM score | 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| mortality rate | death rate at 1 month | 1 month |
| Duration of hospital stay | Duration of hospital stay | 1month |
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Inclusion Criteria:patients with severe traumatic head injury GCS ≤8 both sexes.
>16yrs,
-
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Islam Abd El Aal Helmy | Contact | +20 1068825066 | islamabdelal3@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23872079 | Result | Brooks JC, Strauss DJ, Shavelle RM, Paculdo DR, Hammond FM, Harrison-Felix CL. Long-term disability and survival in traumatic brain injury: results from the National Institute on Disability and Rehabilitation Research Model Systems. Arch Phys Med Rehabil. 2013 Nov;94(11):2203-9. doi: 10.1016/j.apmr.2013.07.005. Epub 2013 Jul 16. | |
| 9726257 |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Intramuscular injection of progesterone
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| The usual head trauma care | Drug | the basic treatment |
|
| Duration of mechanical ventilator | Duration of mechanical ventilator | 1month |
| adverse events | adverse events | 1 month |
| Gcs | Gcs | 1 year |
| Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573. |
| 46957 | Result | Jennett B, Bond M. Assessment of outcome after severe brain damage. Lancet. 1975 Mar 1;1(7905):480-4. doi: 10.1016/s0140-6736(75)92830-5. |
| 21851230 | Result | Sarkaki AR, Khaksari Haddad M, Soltani Z, Shahrokhi N, Mahmoodi M. Time- and dose-dependent neuroprotective effects of sex steroid hormones on inflammatory cytokines after a traumatic brain injury. J Neurotrauma. 2013 Jan 1;30(1):47-54. doi: 10.1089/neu.2010.1686. Epub 2012 Nov 16. |
| 23296919 | Result | Finnie JW. Neuroinflammation: beneficial and detrimental effects after traumatic brain injury. Inflammopharmacology. 2013 Aug;21(4):309-20. doi: 10.1007/s10787-012-0164-2. Epub 2013 Jan 8. |
| 17826908 | Result | VanLandingham JW, Cekic M, Cutler S, Hoffman SW, Stein DG. Neurosteroids reduce inflammation after TBI through CD55 induction. Neurosci Lett. 2007 Sep 25;425(2):94-8. doi: 10.1016/j.neulet.2007.08.045. Epub 2007 Aug 25. |
| 32722286 | Result | Guennoun R. Progesterone in the Brain: Hormone, Neurosteroid and Neuroprotectant. Int J Mol Sci. 2020 Jul 24;21(15):5271. doi: 10.3390/ijms21155271. |
| 17573392 | Result | Werner C, Engelhard K. Pathophysiology of traumatic brain injury. Br J Anaesth. 2007 Jul;99(1):4-9. doi: 10.1093/bja/aem131. |
| 33956297 | Result | Thapa K, Khan H, Singh TG, Kaur A. Traumatic Brain Injury: Mechanistic Insight on Pathophysiology and Potential Therapeutic Targets. J Mol Neurosci. 2021 Sep;71(9):1725-1742. doi: 10.1007/s12031-021-01841-7. Epub 2021 May 6. |
| 20108447 | Result | Management of Concussion/mTBI Working Group. VA/DoD Clinical Practice Guideline for Management of Concussion/Mild Traumatic Brain Injury. J Rehabil Res Dev. 2009;46(6):CP1-68. No abstract available. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |