Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborators:
Hospital Central "Dr. Ignacio Morones Prieto"
AstraZeneca
Information provided by:
Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:
NCT00990028
First received: October 5, 2009
Last updated: October 5, 2011
Last verified: October 2009
  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

Resource links provided by NLM:


Further study details as provided by Universidad Autonoma de San Luis Potosí:

Primary Outcome Measures:
  • Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990028

Locations
Mexico
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
  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
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases
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 April 17, 2014