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The goal of this clinical trial is to learn if standard-dose methylprednisolone sodium succinate can improve neurological recovery and safety in adults with moderate to severe traumatic brain injury (TBI). The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methylprednisolone | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of Glasgow Outcome Scale-Extended (GOS-E) scores at 180 days. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 180 days | |
| Proportion of patients with good neurological outcome (GOS-E 6-8) | 180 days | |
| Incidence of adverse events after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27654000 | Background | Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432. | |
| 15474134 |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Methylprednisolone (MP) | Drug | 2 mg/kg diluted in 100 mL of normal saline (maximum dose 160 mg) , IV once daily for 5 days |
|
| 30 days |
| Roberts I, Yates D, Sandercock P, Farrell B, Wasserberg J, Lomas G, Cottingham R, Svoboda P, Brayley N, Mazairac G, Laloe V, Munoz-Sanchez A, Arango M, Hartzenberg B, Khamis H, Yutthakasemsunt S, Komolafe E, Olldashi F, Yadav Y, Murillo-Cabezas F, Shakur H, Edwards P; CRASH trial collaborators. Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial. Lancet. 2004 Oct 9-15;364(9442):1321-8. doi: 10.1016/S0140-6736(04)17188-2. |
| 40167167 | Background | He C, Wang Y, Gong W, Zhang S. Targeted Delivery of Acid-Responsive Rutin Nanoparticles Based on Aldehyde Adsorption for the Treatment of Spinal Cord Injury in Rats. ACS Biomater Sci Eng. 2025 Apr 14;11(4):2192-2202. doi: 10.1021/acsbiomaterials.5c00038. Epub 2025 Apr 1. |
| 31960811 | Background | Chen X, Chai Y, Wang SB, Wang JC, Yue SY, Jiang RC, Zhang JN. Risk factors for corticosteroid insufficiency during the sub-acute phase of acute traumatic brain injury. Neural Regen Res. 2020 Jul;15(7):1259-1265. doi: 10.4103/1673-5374.272611. |
| 33100225 | Background | Zhang B, Bai M, Xu X, Yang M, Niu F, Gao F, Liu B. Corticosteroid receptor rebalancing alleviates critical illness-related corticosteroid insufficiency after traumatic brain injury by promoting paraventricular nuclear cell survival via Akt/CREB/BDNF signaling. J Neuroinflammation. 2020 Oct 25;17(1):318. doi: 10.1186/s12974-020-02000-2. |
| 31358617 | Background | Liu Z, Yang Y, He L, Pang M, Luo C, Liu B, Rong L. High-dose methylprednisolone for acute traumatic spinal cord injury: A meta-analysis. Neurology. 2019 Aug 27;93(9):e841-e850. doi: 10.1212/WNL.0000000000007998. Epub 2019 Jul 29. |
| 39876698 | Background | Zhang Y, Xiao S, Zhu L, Gan X, Huang Y, Dan F, Chen J, Zhou R, Tang W, Liu J, Liu Z. Effect of Low-dose Methylprednisolone in Promoting Neurological Function Recovery After Spinal Cord Injury: Clinical and Animal Studies. Spine (Phila Pa 1976). 2025 Jul 15;50(14):965-974. doi: 10.1097/BRS.0000000000005269. Epub 2025 Jan 29. |
| 39964685 | Background | Zheng C, Li R, Shen C, Guo F, Fan D, Yang L, Zhang L, Chen A, Chen Y, Chen D, Zi W, Guo C, Nguyen TN, Albers GW, Campbell BCV, Qiu Z, Hu Z. Methylprednisolone as Adjunct to Thrombectomy for Acute Intracranial Internal Carotid Artery Occlusion Stroke: Post Hoc Secondary Analysis of the MARVEL Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459945. doi: 10.1001/jamanetworkopen.2024.59945. |
| 39970603 | Background | Wang B, Zhang Q, Liu C, Chen X. Counteracting immunodepression by extracellular matrix hydrogel to promote brain tissue remodeling and neurological function recovery after traumatic brain injury. Biomaterials. 2025 Jul;318:123181. doi: 10.1016/j.biomaterials.2025.123181. Epub 2025 Feb 8. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |