Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Rosuvastatin on Immunological Markers After Traumatic Brain Injury: Clinical Randomized Double Blind Study Phase 2|
- Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
- Functional outcome by Disability Rating Scale [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
- change of lesions on CT scan [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
- Determination of CK, AST, ALT [ Time Frame: 3rd and 7th day ] [ Designated as safety issue: Yes ]
- Amnesia time using GOAT Score [ Time Frame: in-patient follow-up, after 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Study Completion Date:||August 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
20 mg oral during 10 days
20 mg oral, for 10 days
Other Name: Crestor
|Placebo Comparator: Placebo||
20 mg vehicle
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990028
|Hospital Central "Dr. Ignacio Morones Prieto"|
|San Luis Potosi, Mexico, 78420|
|Study Chair:||Antonio Gordillo-Moscoso, PhD||Clinical Epidemiology UASLP|
|Principal Investigator:||Martin Sanchez-Aguilar, MSc||Clinical epidemiology UASLP|