drugset / Trial / NCT06631547
Effect of Progesterone Administration on Severely Head Injured Patients
RandomizedParallel-groupOpen-labelPrevention
Summary
To investigate the effectiveness of progesterone as a neuroprotective in patients severe traumatic brain injury in clinical outcome
Timeline
- Start
- 2025-12-01
- Primary completion
- 2027-01-31
- Completion
- 2027-07-01
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results Guennoun R. Progesterone in the Brain: Hormone, Neurosteroid and Neuroprotectant. Int J Mol Sci. 2020 Jul 24;21(15):5271. doi: 10.3390/ijms21155271.
- Results Werner C, Engelhard K. Pathophysiology of traumatic brain injury. Br J Anaesth. 2007 Jul;99(1):4-9. doi: 10.1093/bja/aem131.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Progesterone | Other / unclassified | 1 mg/kg | — |