Effect of Rosuvastatin on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Moderate Head Injury
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Rosuvastatin´s Effect on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Humans With Moderate Head Injury|
- Galveston Orientation and Amnesia Test [ Time Frame: Days in be positive ] [ Designated as safety issue: No ]
- Functional outcome by Disability Rating Scale [ Time Frame: at 0 (release) and 3 months ] [ Designated as safety issue: No ]
- Cytosines (Il-1B, IL-6, TNF-alfa) [ Time Frame: Basal and day 3 ] [ Designated as safety issue: No ]
- acute renal Insuficience [ Time Frame: Periode of medication (10 days) ] [ Designated as safety issue: Yes ]
- Lesion on CT scan [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
20 mg oral, during 10 days
Other Name: Crestor
|Placebo Comparator: 2||Drug: Placebo|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329758
|Hospital Central "Dr. Ignacio Morones Prieto"|
|San Luis Potosi, Mexico, 78240|
|Study Director:||Jaime Torres-Corzo, Neurosurgeon||Hospital Central "Dr. Ignacio Morones Prieto"|
|Principal Investigator:||Humberto Tapia-Perez, MD||Facultad de Medicina UASLP|