Clinical trial NCT06631547: Effect of Progesterone Administration on Severely Head Injured Patients
Official title: Effect of Progesterone Administration on Severely Head Injured Patients: Hospital Based Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Severe Head Trauma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intramuscular injection of progesterone
Primary purpose: PREVENTION

Brief summary: To investigate the effectiveness of progesterone as a neuroprotective in patients severe traumatic brain injury in clinical outcome


Eligibility criteria: 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

Primary outcomes:
measure: Glasgow outcome scale GOS-E score
timeFrame: 1year
measure: FIM score
timeFrame: 1 year
Secondary outcomes:
measure: mortality rate
timeFrame: 1 month
measure: Duration of hospital stay
timeFrame: 1month
measure: Duration of mechanical ventilator
timeFrame: 1month
measure: adverse events
timeFrame: 1 month
measure: Gcs
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
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citation: 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.
citation: Guennoun R. Progesterone in the Brain: Hormone, Neurosteroid and Neuroprotectant. Int J Mol Sci. 2020 Jul 24;21(15):5271. doi: 10.3390/ijms21155271.
citation: Werner C, Engelhard K. Pathophysiology of traumatic brain injury. Br J Anaesth. 2007 Jul;99(1):4-9. doi: 10.1093/bja/aem131.
citation: 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.
citation: Department Of Defense Washington DC. VA/DoD Clinical Practice Guideline for Management of Concussion/Mild Traumatic Brain Injury (mTBI). Ft. Belvoir: Defense Technical Information Center; 2009