Phase II Study of Rosuvastatin´s Effect on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Humans With Moderate Head Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Galveston Orientation and Amnesia Test
研究概览
简要总结
The purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation.
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. The management today is trying to avoid progression in secondary damage without good outcome. Many drugs and measures has been ineffective.
In the last years has been demonstrated in head injury microvascular damage like stroke. 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.
We have designed this study for demonstrate if the administration of rosuvastatin in the first 24 hours and by 10 days has improvement in amnesia and orientation, furthermore outcome.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman >16 and <50 years with HI less 24 hours in progression and Glasgow between 9 y
- •Man or woman >16 and <50 years with HI and Glasgow l3, with lesions in TC scan.
- •Acceptance of family to participate (first grade).
排除标准
- •History of HI with disability
- •History of neurological or psychiatric disease with disability.
- •Administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone.
- •Existence of systemic injury with life in compromise (massive bleeding, exposition of bone in fracture, hepatic or splenic laceration or in great vessels and shock).
- •Administration of THAM, mannitol, barbiturates, corticosteroids, scavengers of free radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist, antagonists of neurotransmitters
- •Existence of intracranial lesion which needs surgery.
- •Lesions not classifiable or in brainstem.
- •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
1
干预措施: rosuvastatin (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Galveston Orientation and Amnesia Test
时间窗: Days in be positive
次要结局
- Lesion on CT scan(72 hours)
- Functional outcome by Disability Rating Scale(at 0 (release) and 3 months)
- Cytosines (Il-1B, IL-6, TNF-alfa)(Basal and day 3)
- acute renal Insuficience(Periode of medication (10 days))