Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury

Head Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990028
• Other study ID #: 28-09ROHI
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 5, 2009
• Last updated: October 5, 2011
• Start date: August 2009
• Est. completion date: August 2011

Study information

• Verified date: October 2009
• Source: Universidad Autonoma de San Luis Potosí
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Craniocerebral Trauma
• Head Injury

Intervention

Drug:
• Rosuvastatin
20 mg oral, for 10 days
• Placebo
20 mg vehicle

Locations

Country	Name	City	State
Mexico	Hospital Central "Dr. Ignacio Morones Prieto"	San Luis Potosi

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí	AstraZeneca, Hospital Central "Dr. Ignacio Morones Prieto"

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

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. Review. Spanish. — View Citation

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. — View Citation

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. — View Citation

Tapia-Pérez 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL)		Day 3	No
Secondary	Functional outcome by Disability Rating Scale		after 3 months	No
Secondary	change of lesions on CT scan		72 hours	No
Secondary	Determination of CK, AST, ALT		3rd and 7th day	Yes
Secondary	Amnesia time using GOAT Score		in-patient follow-up, after 3 months	No