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Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT00990028
Recruitment Status : Completed
First Posted : October 6, 2009
Last Update Posted : October 6, 2011
Sponsor:
Collaborators:
Hospital Central "Dr. Ignacio Morones Prieto"
AstraZeneca
Information provided by:
Universidad Autonoma de San Luis Potosí

October 5, 2009
October 6, 2009
October 6, 2011
August 2009
July 2011   (Final data collection date for primary outcome measure)
Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL) [ Time Frame: Day 3 ]
Cytosines (Il-1B, IL-6, TNF-alfa) [ Time Frame: Basal and day 3 ]
Complete list of historical versions of study NCT00990028 on ClinicalTrials.gov Archive Site
  • Functional outcome by Disability Rating Scale [ Time Frame: after 3 months ]
  • change of lesions on CT scan [ Time Frame: 72 hours ]
  • Determination of CK, AST, ALT [ Time Frame: 3rd and 7th day ]
  • Amnesia time using GOAT Score [ Time Frame: in-patient follow-up, after 3 months ]
  • Galveston Orientation and Amnesia Test [ Time Frame: Days until positive ]
  • Functional outcome by Disability Rating Scale [ Time Frame: at 0 (release), 3 and 6 months ]
  • Lesion on CT scan [ Time Frame: 72 hours ]
  • Determination of CK, AST, ALT [ Time Frame: 0, 3, 7 days after randimization ]
Not Provided
Not Provided
 
Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury
Effect of Rosuvastatin on Immunological Markers After Traumatic Brain Injury: Clinical Randomized Double Blind Study Phase 2
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Head Injury
  • Drug: Rosuvastatin
    20 mg oral, for 10 days
    Other Name: Crestor
  • Drug: Placebo
    20 mg vehicle
  • Experimental: Rosuvastatin
    20 mg oral during 10 days
    Intervention: Drug: Rosuvastatin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Same as current
August 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 60 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT00990028
28-09ROHI
Yes
Not Provided
Not Provided
Dr. Martin Sanchez, Clinical Epidemiology UASLP
Universidad Autonoma de San Luis Potosí
  • Hospital Central "Dr. Ignacio Morones Prieto"
  • AstraZeneca
Study Chair: Antonio Gordillo-Moscoso, PhD Clinical Epidemiology UASLP
Principal Investigator: Martin Sanchez-Aguilar, MSc Clinical epidemiology UASLP
Universidad Autonoma de San Luis Potosí
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP