IMPROVING OUTCOME IN SEVERE HEAD INJURY - PEG-SOD TRIAL

改善严重头部损伤的结果 - PEG-SOD 试验

• 批准号: 3416067
• 负责人: HAROLD F YOUNG
• 金额: $ 54.79万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-04-01 至 1996-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3416067
• 关键词: antioxidants; blood chemistry; brain injury; cerebrospinal fluid; clinical trials; cooperative study; dosage forms; drug design /synthesis /production; drug screening /evaluation; eicosanoid metabolism; free radicals; head /neck injury; human subject; human therapy evaluation; lipid peroxides; longitudinal human study; superoxide dismutase; vasomotion

Head injury is still a major cause of death and disability despite the implementation of aggressive methods of evaluation and intensive care. It is our feeling that if further gains are to be made in improving patient outcome, new efforts must be directed at the basic pathophysiologic processes involved in severe head injury. Based upon extensive data obtained in our laboratories, we have chosen to target our therapeutic efforts at the damaging consequences of oxygen radicals on the cerebral vasculature. Specifically, the hypothesis is that the action of free radicals on the cerebral vasculature contributes significantly to the morbidity and mortality of severe head injury, and quenching of free radicals with PEG-SOD* can improve the outcome in patients with severe head injury. To prove this hypothesis, we will conduct a prospective, randomized, double-blind, Phase III trial. The patients will be divided for the Phase III trial into 2 groups: (1) a control group, and (2) a group treated with PEG-SOD. The efficacy of this agent will be measured by the Glasgow Outcome Score (GOS) at one year, as well as by other measures of outcome, specifically the Disability Rating Scale (DRS) and the Los Ranchos Amigos Outcome Scale. Other measures of efficacy will also be used; these include dynamic intracranial pressure (ICP) monitoring coupled with measurements of vascular reactivity, the neurologic exam, and biochemical assays of appropriate products of lipid peroxidation.

头部受伤仍然是死亡和残疾的主要原因， 实施积极的评估和重症监护方法。 它 我们的感觉是，如果要在改善患者 结果，新的努力必须针对基本的病理生理学 严重头部损伤的过程。 基于大量数据 在我们的实验室中获得，我们选择将我们的治疗方法 努力研究氧自由基对大脑的破坏性后果， 脉管系统 具体地说，假设是，自由的行动， 自由基对脑血管系统的贡献显着 重型颅脑损伤的发病率和死亡率，以及游离 自由基与PEG-SOD* 联合应用可改善重型颅脑损伤患者的预后 损伤 为了证明这一假设，我们将进行一项前瞻性的， 随机、双盲、III期试验。 病人将被分开 III期试验分为2组：（1）对照组，和（2） 用PEG-SOD处理。 该药物的疗效将通过以下方法进行测量： 1年时的格拉斯哥结局评分（GOS）以及其他指标， 结果，特别是残疾评定量表（DRS）和Los Ranchos 朋友结局量表。 还将使用其他疗效指标;这些 包括动态颅内压（ICP）监测， 血管反应性测量、神经学检查和生化检查。 适当的脂质过氧化产物的测定。