Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury

Sponsor

Universidad Autonoma de San Luis Potosí (Other)

Overall Status

Completed

CT.gov ID

NCT00990028

Collaborator

Hospital Central "Dr. Ignacio Morones Prieto" (Other), AstraZeneca (Industry)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Head Injury	Drug: Rosuvastatin Drug: Placebo	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Effect of Rosuvastatin on Immunological Markers After Traumatic Brain Injury: Clinical Randomized Double Blind Study Phase 2

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rosuvastatin 20 mg oral during 10 days	Drug: Rosuvastatin 20 mg oral, for 10 days Other Names: Crestor
Placebo Comparator: Placebo	Drug: Placebo 20 mg vehicle

Arm

Intervention/Treatment

Experimental: Rosuvastatin

20 mg oral during 10 days

Drug: Rosuvastatin

20 mg oral, for 10 days

Other Names:

Crestor

Placebo Comparator: Placebo

Drug: Placebo

20 mg vehicle

Outcome Measures

Primary Outcome Measures

Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL) [Day 3]

Secondary Outcome Measures

Functional outcome by Disability Rating Scale [after 3 months]
change of lesions on CT scan [72 hours]
Determination of CK, AST, ALT [3rd and 7th day]
Amnesia time using GOAT Score [in-patient follow-up, after 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Central "Dr. Ignacio Morones Prieto"	San Luis Potosi		Mexico	78420

Sponsors and Collaborators

Universidad Autonoma de San Luis Potosí
Hospital Central "Dr. Ignacio Morones Prieto"
AstraZeneca

Investigators

Study Chair: Antonio Gordillo-Moscoso, PhD, Clinical Epidemiology UASLP
Principal Investigator: Martin Sanchez-Aguilar, MSc, Clinical epidemiology UASLP