Effect of Progesterone Administration on Severely Head Injured Patients
NCT ID: NCT06631547
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2025-12-01
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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patients with main lines of management without progesterone
patients with main lines of management without progesterone
The usual head trauma care
the basic treatment
Patients taking progesterone plus the main lines of management of traumatic brain injury
taking progesterone IM 1mg/kg twice for 5 days plus the main lines of management of traumatic brain injury
Progesterone
Hormonal treatment
The usual head trauma care
the basic treatment
Interventions
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Progesterone
Hormonal treatment
The usual head trauma care
the basic treatment
Eligibility Criteria
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Inclusion Criteria
\-
Exclusion Criteria
* 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
16 Years
100 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Islam Abd El Aal Helmy
Resident
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
Guennoun R. Progesterone in the Brain: Hormone, Neurosteroid and Neuroprotectant. Int J Mol Sci. 2020 Jul 24;21(15):5271. doi: 10.3390/ijms21155271.
Werner C, Engelhard K. Pathophysiology of traumatic brain injury. Br J Anaesth. 2007 Jul;99(1):4-9. doi: 10.1093/bja/aem131.
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.
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
Other Identifiers
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Pgs in head trauma
Identifier Type: -
Identifier Source: org_study_id
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