Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury - Full Text View

Sponsor:	Universidad Autonoma de San Luis Potosí
Collaborators:	Hospital Central "Dr. Ignacio Morones Prieto" AstraZeneca
Information provided by:	Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:	NCT00990028

Purpose

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.

Condition	Intervention	Phase
Head Injury	Drug: Rosuvastatin Drug: Placebo	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Effect of Rosuvastatin on Immunological Markers After Traumatic Brain Injury: Clinical Randomized Double Blind Study Phase 2

Resource links provided by NLM:

MedlinePlus related topics: Head Injuries Traumatic Brain Injury

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Universidad Autonoma de San Luis Potosí:

Primary Outcome Measures:

Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Functional outcome by Disability Rating Scale [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
change of lesions on CT scan [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Determination of CK, AST, ALT [ Time Frame: 3rd and 7th day ] [ Designated as safety issue: Yes ]
Amnesia time using GOAT Score [ Time Frame: in-patient follow-up, after 3 months ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	August 2009
Study Completion Date:	August 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rosuvastatin 20 mg oral during 10 days	Drug: Rosuvastatin 20 mg oral, for 10 days Other Name: Crestor
Placebo Comparator: Placebo	Drug: Placebo 20 mg vehicle

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 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.

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Man or woman > 16 and < 60 years old 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990028

Locations

Mexico
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosi, Mexico, 78420

Sponsors and Collaborators

Universidad Autonoma de San Luis Potosí

Hospital Central "Dr. Ignacio Morones Prieto"

AstraZeneca

Investigators

Study Chair:	Antonio Gordillo-Moscoso, PhD	Clinical Epidemiology UASLP
Principal Investigator:	Martin Sanchez-Aguilar, MSc	Clinical epidemiology UASLP

More Information

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.

Tapia-Pérez JH, Sanchez-Aguilar M, Schneider T. The role of statins in neurosurgery. Neurosurg Rev. 2010 Jul;33(3):259-70; discussion 270. Epub 2010 Apr 29.

Responsible Party:	Dr. Martin Sanchez, Clinical Epidemiology UASLP
ClinicalTrials.gov Identifier:	NCT00990028 History of Changes
Other Study ID Numbers:	28-09ROHI
Study First Received:	October 5, 2009
Last Updated:	October 5, 2011
Health Authority:	Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Universidad Autonoma de San Luis Potosí:

moderate head injury
rosuvastatin
statin
amnesia
orientation

Additional relevant MeSH terms:

Craniocerebral Trauma
Brain Injuries
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012