Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury

Universidad Autonoma de San Luis Potosí

Status and phase

Completed

Phase 2

Phase 1

Conditions

Head Injury

Treatments

Drug: Rosuvastatin

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00990028

28-09ROHI

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment

40 patients

Sex

All

Ages

16 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Man or woman > 16 and < 60 years old with HI less 24 hours in progression and Glasgow between < 13
Acceptance of family to participate (first grade)

Exclusion criteria

Previous head injury with severe disability
History of neurological or psychiatric disease with severe disability
Administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone
Very poor possibilities for survival
Use of Administration of THAM, mannitol, barbiturates, corticosteroids, scavengers of free radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist, antagonists of neurotransmitters before randomization
isolated lesions in brain stem
Allergy to the drug
Hepatopathy or myopathy (or) history of this, or clinical data of hepatic disease
Management previous in other Hospital
Pregnancy