Head Injury
Conditions
Keywords
moderate head injury, rosuvastatin, statin, amnesia, orientation
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 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.
Interventions
DRUGrosuvastatin
20 mg oral, during 10 days
DRUGPlacebo
Sponsors
Hospital Central Dr. Ignacio Morones Prieto
AstraZeneca
Universidad Autonoma de San Luis Potosí
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Galveston Orientation and Amnesia Test | Days in be positive |
Secondary
| Measure | Time frame |
|---|---|
| Functional outcome by Disability Rating Scale | at 0 (release) and 3 months |
| Cytosines (Il-1B, IL-6, TNF-alfa) | Basal and day 3 |
| acute renal Insuficience | Periode of medication (10 days) |
| Lesion on CT scan | 72 hours |
Countries
Mexico
Outcome results
None listed