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临床试验/NCT00990028
NCT00990028已完成1 期

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

Universidad Autonoma de San Luis Potosí1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa) (pg/dL)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Rosuvastatin

Experimental

20 mg oral during 10 days

干预措施: Rosuvastatin (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

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

时间窗: Day 3

次要结局

  • 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)

研究者

申办方类型
Other

研究点 (1)

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