Status:
COMPLETED
Effect of Rosuvastatin on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Moderate Head Injury
Lead Sponsor:
Universidad Autonoma de San Luis Potosí
Collaborating Sponsors:
Hospital Central "Dr. Ignacio Morones Prieto"
AstraZeneca
Conditions:
Head Injury
Eligibility:
All Genders
16-50 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation.
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 expe...
Eligibility Criteria
Inclusion
- Man or woman \>16 and \<50 years with HI less 24 hours in progression and Glasgow between 9 y 12.
- Man or woman \>16 and \<50 years with HI and Glasgow l3, with lesions in TC scan.
- Acceptance of family to participate (first grade).
Exclusion
- History of HI with disability
- History of neurological or psychiatric disease with disability.
- Administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone.
- Existence of systemic injury with life in compromise (massive bleeding, exposition of bone in fracture, hepatic or splenic laceration or in great vessels and shock).
- Administration of THAM, mannitol, barbiturates, corticosteroids, scavengers of free radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist, antagonists of neurotransmitters
- Existence of intracranial lesion which needs surgery.
- Lesions not classifiable or in brainstem.
- Allergy to the drug.
- Hepatopathy or myopathy (or) history of this, or clinical data of hepatic disease.
- Management previous in other Hospital.
- Pregnancy
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00329758
Start Date
July 1 2006
End Date
October 1 2007
Last Update
June 24 2010
Active Locations (1)
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1
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, San Luis Potosí, Mexico, 78240