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| Name | Class |
|---|---|
| Hospital Central "Dr. Ignacio Morones Prieto" | OTHER |
| AstraZeneca | INDUSTRY |
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The purpose of this study is to determine whether rosuvastatin could alter the immunological response after head injury by modulating TNF-alpha,IL6,IL-1.
The head injury is a frequent problem of health, which produces high morbid-mortality. Today is the main cause of death and disability between 18 and 40 years. In addition it originates expensive expenses in health care systems.
Head injury produces damage by primary mechanisms related to impact, then by biochemical ways which are activated and they carry to secondary damage. Many studies have been conducted for explaining secondary injury, the majority conclude there is a kind of ischemic lesion related maybe with changes in cerebral flow and metabolism. All these changes are associated to a immunological response. Up to now some drugs are directed to modulate the immunological system, although many of them have been ineffective.
Statins o inhibitors of HMG CoA reductase are drugs used in dyslipidemia, frequently for reduction in LDL. Experimental and clinical studies in stroke have shown improvement in outcome. The toxicity related to statin is myopathy and hepatopathy, both with low incidence without fatal cases. Rosuvastatin has been postulated be the most powerful with longest life and toxicity similar to another statins. Many studies have suggested an important immunomodulator effect after statins administration, The investigators have previously demonstrated the possible effect of statin on amnesia and disorientation improvement with patients who suffered a moderated head injury (Glasgow 9-13). The aim of this new study is to analyze the possible immunomodulator role of statins on head injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Experimental | 20 mg oral during 10 days |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 20 mg oral, for 10 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL) | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome by Disability Rating Scale | after 3 months | |
| change of lesions on CT scan | 72 hours | |
| Determination of CK, AST, ALT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Gordillo-Moscoso, PhD | Clinical Epidemiology UASLP | Study Chair |
| Martin Sanchez-Aguilar, MSc | Clinical epidemiology UASLP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Central "Dr. Ignacio Morones Prieto" | San Luis Potosà City | San Luis Potosà | 78420 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17899518 | Background | Tapia-Perez H, Sanchez-Aguilar M, Torres-Corzo J, Rodriguez-Leyva I, Herrera-Gonzalez LB. [Statins and brain protection mechanisms]. Rev Neurol. 2007 Sep 16-30;45(6):359-64. Spanish. | |
| 18690806 | Background | Tapia-Perez J, Sanchez-Aguilar M, Torres-Corzo JG, Gordillo-Moscoso A, Martinez-Perez P, Madeville P, de la Cruz-Mendoza E, Chalita-Williams J. Effect of rosuvastatin on amnesia and disorientation after traumatic brain injury (NCT003229758). J Neurotrauma. 2008 Aug;25(8):1011-7. doi: 10.1089/neu.2008.0554. |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D000647 | Amnesia |
| D000072458 | Orientation, Spatial |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D008569 | Memory Disorders |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Placebo | Drug | 20 mg vehicle |
|
| 3rd and 7th day |
| Amnesia time using GOAT Score | in-patient follow-up, after 3 months |
| 19197830 | Background | Tapia-Perez H, Sanchez-Aguilar M, Torres-Corzo JG, Rodriguez-Leyva I, Gonzalez-Aguirre D, Gordillo-Moscoso A, Chalita-Williams C. Use of statins for the treatment of spontaneous intracerebral hemorrhage: results of a pilot study. Cent Eur Neurosurg. 2009 Feb;70(1):15-20. doi: 10.1055/s-0028-1082064. Epub 2009 Feb 5. |
| 20429022 | Background | Tapia-Perez JH, Sanchez-Aguilar M, Schneider T. The role of statins in neurosurgery. Neurosurg Rev. 2010 Jul;33(3):259-70; discussion 270. doi: 10.1007/s10143-010-0259-4. Epub 2010 Apr 29. |
| 23289819 | Derived | Sanchez-Aguilar M, Tapia-Perez JH, Sanchez-Rodriguez JJ, Vinas-Rios JM, Martinez-Perez P, de la Cruz-Mendoza E, Sanchez-Reyna M, Torres-Corzo JG, Gordillo-Moscoso A. Effect of rosuvastatin on cytokines after traumatic head injury. J Neurosurg. 2013 Mar;118(3):669-75. doi: 10.3171/2012.12.JNS121084. Epub 2013 Jan 4. |
| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013037 | Spatial Behavior |
| D001519 | Behavior |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |