NATIONAL ACUTE BRAIN INJURY STUDY--HYPOTHERMIA

国家急性脑损伤研究--体温过低

• 批准号: 2271211
• 负责人: Guy L. Clifton
• 金额: $ 262.41万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-15 至 1998-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2271211
• 关键词: acute disease /disorder; brain injury; clinical trials; emergency care; human mortality; human subject; human therapy evaluation; induced hypothermia; medical complication; neuropsychological tests; psychomotor function; trauma

The purpose of this study is to test the efficacy and safety of forty- eight hours of systemic hypothermia induced by surface cooling within six hours of traumatic brain injury. The primary end point of this Phase III trial will be to determine whether functional deficits as measured by the Glasgow outcome scale (GOS) are improved in the treatment group relative to a control population six months after the injury. The secondary hypotheses include a variety of neuropsychological measurements, determination of whether hypothermia reduces mortality within three months after severe traumatic brain injury and whether hypothermia reduces the incidence of post-traumatic and idiopathic seizures relative to untreated patients. The sample size will be 250 per group in this two armed trial that will be stratified on the basis of post resuscitation motor function. It is anticipated that the study should take somewhat more than three years to complete. This amended proposal was initially reviewed in October, 1993. It is well established that acute brain injury reduces neurological damage in a variety of situations and the investigators have already conducted - two Phase II trials of surface induced moderate hypothermia. These studies have shown an absolute improvement in the percentage of patients achieving good outcomes at three months without serious hypothermia related complications, although these studies were not large enough to show significant differences. These pilot studies did demonstrate the feasibility of the proposed procedures, and all of the centers are part of emergency medical service systems with rapid transport times. The study is designed to be able to detect a shift of ten percent in patients achieving a good rather than poor recovery. Traumatic brain injury is often an especially severe problem because the victims are young and previously healthy. The injury is unanticipated, and the victims may survive for extended periods because their general medical health is good. But, because of their mental impairments they are often unable to be productive members of society and frequently are a serious financial burden to their families. This is, of course, in addition to the serious emotional consequences of such devastating losses. The investigators cite a variety of animal models showing that hypothermia induced rapidly after the onset of acute brain injury reduces neurologic injury. Although the mechanisms of damage reduction by hypothermia are not yet adequately understood, the detailed pathogenesis of this process is not the major focus of this proposed investigation. The preliminary results of the Phase II trials are quite promising, and it is likely that the proposed study will be pivotal in demonstrating efficacy of a clinically practical treatment modality. If this study shows significant hypothermia induced reduction in brain damage, it is probable that major changes in the care of large numbers of trauma patients will follow.

这项研究的目的是测试40-4的功效和安全性 八个小时的全身性低温诱导的表面冷却引起 六个小时的创伤性脑损伤。 主要终点 第三阶段试验将确定功能缺陷是否为 通过格拉斯哥结果量表（GOS）测量的治疗方法得到改善 受伤六个月后的群体相对于对照人群。 这 次要假设包括各种神经心理学 测量值，确定体温过低是否降低死亡率 在严重的脑损伤后三个月内，是否 体温过低会降低创伤后和特发性的发生率 相对于未治疗的患者癫痫发作。 样本量为250 在这两个武装审判中的小组将根据 后复苏运动功能。 预计该研究 应该花费三年多的时间才能完成。这修改了 提案最初于1993年10月进行了审查。 众所周知，急性脑损伤会减少神经系统损伤 在各种情况下的损害，调查人员已经 进行 - 表面诱导中度体温过低的两次II期试验。 这些研究表明，百分比的百分比有了绝对的改善 患者在三个月内取得良好的结果而没有严重 低温相关的并发症，尽管这些研究并不大 足以显示显着差异。 这些试点研究确实 证明拟议程序的可行性以及所有 中心是快速的紧急医疗服务系统的一部分 运输时间。 该研究旨在检测 在恢复良好而不是恢复不良的患者中，有百分之十。 创伤性脑损伤通常是一个特别严重的问题，因为 受害者年轻，以前健康。 伤害是意外的， 受害者可能会长时间生存，因为他们的一般 医疗健康很好。 但是，由于他们的精神障碍 通常无法成为社会的生产成员，并且经常是 给家人带来严重的经济负担。当然，这是 加上这种毁灭性的严重情感后果 损失。 调查人员引用了各种动物模型，表明 急性脑损伤发作后，体温过低迅速诱导 减少神经损伤。 虽然减少伤害的机制 通过体温过低，尚未充分理解 该过程的发病机理不是该提出的主要重点 调查。 II期试验的初步结果非常 有希望的，拟议的研究很可能是关键的 证明临床实用治疗方式的功效。 如果 这项研究表明明显的体温过低会诱发大脑的减少 损坏，很可能会发生大量护理的重大变化 创伤患者将跟随。