Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury

NCT00990028 | Completed Phase 1 DMC

• 1 other identifier: 28-09ROHI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head Injury

Keywords

moderate head injury; rosuvastatin; statin; amnesia; orientation

Outcome Measures

Primary Outcomes (1)

• Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL)

  Day 3

Secondary Outcomes (4)

• Functional outcome by Disability Rating Scale

  after 3 months

• change of lesions on CT scan

  72 hours

• Determination of CK, AST, ALT

  3rd and 7th day

• Amnesia time using GOAT Score

  in-patient follow-up, after 3 months

Study Arms (2)

Rosuvastatin

EXPERIMENTAL

20 mg oral during 10 days

Drug: Rosuvastatin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rosuvastatin DRUG

20 mg oral, for 10 days

Also known as: Crestor

Rosuvastatin

Placebo DRUG

20 mg vehicle

Placebo

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de San Luis Potosí: lead
• Hospital Central "Dr. Ignacio Morones Prieto": collaborator
• AstraZeneca: collaborator

Study Sites (1)

Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, San Luis Potosí, 78420, Mexico

Location

Related Publications (5)

• 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.

  PMID: 17899518 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.

  PMID: 18690806 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.

  PMID: 19197830 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.

  PMID: 20429022 BACKGROUND

• 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.

  PMID: 23289819 DERIVED

MeSH Terms

Conditions

Craniocerebral Trauma; Amnesia; Orientation, Spatial

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Memory Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Spatial Behavior; Behavior

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Antonio Gordillo-Moscoso, PhD

  Clinical Epidemiology UASLP

  STUDY CHAIR

• Martin Sanchez-Aguilar, MSc

  Clinical epidemiology UASLP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 6, 2009
• Study Start: August 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 6, 2011

Record last verified: 2009-10

Locations

ME (1)