Effect of Rosuvastatin on Cytokins After Traumatic Brain Injury

Condition(s) targeted: Head Injury

Intervention: Rosuvastatin (Drug); Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Universidad Autonoma de San Luis Potosí

Official(s) and/or principal investigator(s):
Antonio Gordillo-Moscoso, PhD, Study Chair, Affiliation: Clinical Epidemiology UASLP
Martin Sanchez-Aguilar, MSc, Principal Investigator, Affiliation: Clinical epidemiology UASLP

Overall contact:
Martin Sanchez-Aguilar, MSc, Phone: 52 444 82 62 350, Ext: 519, Email: jemarsan7@hotmail.com

The purpose of this study is to determine whether rosuvastatin coudl affect the immunological response after head injury by modulating TNF-alphaa,IL6,IL-1.

Official title: Effect of Rosuvastatin on Immunological Markes After Traumatic Brain Injury: Clinical Randomized Double Blind Study Phase 2

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Cytosines (Il-1B, IL-6, TNF-alfa)

Secondary outcome:

Galveston Orientation and Amnesia Test

Functional outcome by Disability Rating Scale

Lesion on CT scan

Determination of CK, AST, ALT

Detailed description: 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 direted to modulate the immunological system, altough 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 immunodulator effect after statins administration, We 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 immunodulator role of statins on head injury.

Minimum age: 16 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Man or woman >16 and <60 years with HI less 24 hours in progression and Glasgow

between <13

- Acceptance of family to participate (first grade).

Exclusion Criteria:

- Previous head injury with severe disability

- 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 radomization

- isolated lesions in brainstem

- Allergy to the drug.

- Hepatopathy or myopathy (or) history of this, or clinical data of hepatic disease.

- Management previous in other Hospital.

- Pregnancy

Martin Sanchez-Aguilar, MSc, Phone: 52 444 82 62 350, Ext: 519, Email: jemarsan7@hotmail.com

Hospital Central "Dr. Ignacio Morones Prieto", San Luis Potosi 78420, Mexico; Recruiting
Martin Sanchez-Aguilar, MSc, Phone: 52 444 82 62 350, Ext: 519, Email: jemarsan7@hotmail.com
Jaime G Torres-Corzo, MD, Principal Investigator
Juan M Vinas-Rios, MD, Sub-Investigator
Patricia Martinez-Perez, MSc, Sub-Investigator

Related publications:

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 JH, 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.

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. Zentralbl Neurochir. 2009 Feb;70(1):15-20. Epub 2009 Feb 5.

Starting date: August 2009
Ending date: August 2010
Last updated: October 5, 2009