Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head Injury |
Drug: Rosuvastatin Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 40 |
| Study Start Date: | August 2009 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rosuvastatin
20 mg oral during 10 days
|
Drug: Rosuvastatin
20 mg oral, for 10 days
Other Name: Crestor
|
| Placebo Comparator: Placebo |
Drug: Placebo
20 mg vehicle
|
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. 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.
Eligibility| Ages Eligible for Study: | 16 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Mexico | |
| 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 |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Martin Sanchez, Clinical Epidemiology UASLP |
| ClinicalTrials.gov Identifier: | NCT00990028 History of Changes |
| Other Study ID Numbers: | 28-09ROHI |
| Study First Received: | October 5, 2009 |
| Last Updated: | October 5, 2011 |
| Health Authority: | Mexico: National Institute of Public Health, Health Secretariat |
Keywords provided by Universidad Autonoma de San Luis Potosí:
|
moderate head injury rosuvastatin statin amnesia orientation |
Additional relevant MeSH terms:
|
Craniocerebral Trauma Brain Injuries Trauma, Nervous System Nervous System Diseases Wounds and Injuries Brain Diseases Central Nervous System Diseases Rosuvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013