Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Autonoma de San Luis Potosí
• Collaborators: AstraZeneca; Hospital Central "Dr. Ignacio Morones Prieto"
• Treatments: Rosuvastatin Calcium

Criteria

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