Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury
NCT ID: NCT00990028
Last Updated: 2011-10-06
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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COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2009-08-31
2011-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Rosuvastatin
20 mg oral during 10 days
Rosuvastatin
20 mg oral, for 10 days
Placebo
Placebo
20 mg vehicle
Interventions
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Rosuvastatin
20 mg oral, for 10 days
Placebo
20 mg vehicle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acceptance of family to participate (first grade)
Exclusion Criteria
* History of neurological or psychiatric disease with severe disability
* Administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone
* Very poor possibilities for survival
* Use of Administration of THAM, mannitol, barbiturates, corticosteroids, scavengers of free radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist, antagonists of neurotransmitters before randomization
* isolated lesions in brain stem
* Allergy to the drug
* Hepatopathy or myopathy (or) history of this, or clinical data of hepatic disease
* Management previous in other Hospital
* Pregnancy
16 Years
60 Years
ALL
No
Sponsors
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Hospital Central "Dr. Ignacio Morones Prieto"
OTHER
AstraZeneca
INDUSTRY
Universidad Autonoma de San Luis Potosí
OTHER
Responsible Party
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Clinical Epidemiology UASLP
Principal Investigators
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Antonio Gordillo-Moscoso, PhD
Role: STUDY_CHAIR
Clinical Epidemiology UASLP
Martin Sanchez-Aguilar, MSc
Role: PRINCIPAL_INVESTIGATOR
Clinical epidemiology UASLP
Locations
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Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, San Luis Potosí, Mexico
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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28-09ROHI
Identifier Type: -
Identifier Source: org_study_id