Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury
Primary Purpose
Head Injury
Status
Completed
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Rosuvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Head Injury focused on measuring moderate head injury, rosuvastatin, statin, amnesia, orientation
Eligibility 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
Sites / Locations
- Hospital Central "Dr. Ignacio Morones Prieto"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rosuvastatin
Placebo
Arm Description
20 mg oral during 10 days
Outcomes
Primary Outcome Measures
Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL)
Secondary Outcome Measures
Functional outcome by Disability Rating Scale
change of lesions on CT scan
Determination of CK, AST, ALT
Amnesia time using GOAT Score
Full Information
NCT ID
NCT00990028
First Posted
October 5, 2009
Last Updated
October 5, 2011
Sponsor
Universidad Autonoma de San Luis Potosí
Collaborators
Hospital Central "Dr. Ignacio Morones Prieto", AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT00990028
Brief Title
Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury
Official Title
Effect of Rosuvastatin on Immunological Markers After Traumatic Brain Injury: Clinical Randomized Double Blind Study Phase 2
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidad Autonoma de San Luis Potosí
Collaborators
Hospital Central "Dr. Ignacio Morones Prieto", AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injury
Keywords
moderate head injury, rosuvastatin, statin, amnesia, orientation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin
Arm Type
Experimental
Arm Description
20 mg oral during 10 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
20 mg oral, for 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
20 mg vehicle
Primary Outcome Measure Information:
Title
Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL)
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Functional outcome by Disability Rating Scale
Time Frame
after 3 months
Title
change of lesions on CT scan
Time Frame
72 hours
Title
Determination of CK, AST, ALT
Time Frame
3rd and 7th day
Title
Amnesia time using GOAT Score
Time Frame
in-patient follow-up, after 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Gordillo-Moscoso, PhD
Organizational Affiliation
Clinical Epidemiology UASLP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Martin Sanchez-Aguilar, MSc
Organizational Affiliation
Clinical epidemiology UASLP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Central "Dr. Ignacio Morones Prieto"
City
San Luis Potosi
ZIP/Postal Code
78420
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
17899518
Citation
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.
Results Reference
background
PubMed Identifier
18690806
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.
Results Reference
background
PubMed Identifier
19197830
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.
Results Reference
background
PubMed Identifier
20429022
Citation
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.
Results Reference
background
PubMed Identifier
23289819
Citation
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.
Results Reference
derived
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Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury
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