Clinical Trial: Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Universidad Autonoma de San Luis Potosí

Current Primary Outcome: Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL) [ Time Frame: Day 3 ]

Original Primary Outcome: Cytosines (Il-1B, IL-6, TNF-alfa) [ Time Frame: Basal and day 3 ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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 ]


Information By: Universidad Autonoma de San Luis Potosí

Dates:
Date Received: October 5, 2009
Date Started: August 2009
Date Completion:
Last Updated: October 5, 2011
Last Verified: October 2009