Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury

October 5, 2011 updated by: Universidad Autonoma de San Luis Potosí

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • San Luis Potosi, Mexico, 78420
        • Hospital Central "Dr. Ignacio Morones Prieto"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
20 mg vehicle
EXPERIMENTAL: Rosuvastatin
20 mg oral during 10 days
Drug: Rosuvastatin
20 mg oral, for 10 days
Other Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL)
Time Frame: Day 3
Day 3

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de San Luis Potosí

Collaborators

AstraZeneca
Hospital Central "Dr. Ignacio Morones Prieto"

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 5, 2009

First Posted (ESTIMATE)

October 6, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 6, 2011

Last Update Submitted That Met QC Criteria

October 5, 2011

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28-09ROHI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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