Head Injury Clinical Trial
Official title:
Phase II Study of Rosuvastatin´s Effect on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Humans With Moderate Head Injury
The purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation.
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. The management today is
trying to avoid progression in secondary damage without good outcome. Many drugs and
measures has been ineffective.
In the last years has been demonstrated in head injury microvascular damage like stroke.
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.
We have designed this study for demonstrate if the administration of rosuvastatin in the
first 24 hours and by 10 days has improvement in amnesia and orientation, furthermore
outcome.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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