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OpenTrials
Completed

NCT Number: NCT00990028

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.

Completed

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Key information

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, San Luis Potosí, 78420, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

20 mg oral, for 10 days

Other names: Crestor

Placebo

Drug

20 mg vehicle

Primary outcomes

  1. Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL)

    Time frame: Day 3

Secondary outcomes

  1. Functional outcome by Disability Rating Scale

    Time frame: after 3 months

  2. change of lesions on CT scan

    Time frame: 72 hours

  3. Determination of CK, AST, ALT

    Time frame: 3rd and 7th day

  4. Amnesia time using GOAT Score

    Time frame: in-patient follow-up, after 3 months

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de San Luis Potosí

Other

Collaborators

  • AstraZeneca
  • Hospital Central "Dr. Ignacio Morones Prieto"

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 6, 2009
Registry last updated
Oct 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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