NATIONAL ACUTE BRAIN INJURY STUDY--HYPOTHERMIA

国家急性脑损伤研究--体温过低

• 批准号: 2717299
• 负责人: Guy L. Clifton
• 金额: $ 3.85万
• 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/2717299
• 关键词: NATIONAL; ACUTE; BRAIN; INJURY; STUDY

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.

本研究的目的是测试四十种药物的有效性和安全性 表面冷却引起的八小时全身低温 六个小时的脑外伤。 本研究的主要终点 第三阶段试验将确定功能缺陷是否为 格拉斯哥结果量表 (GOS) 测量的结果在治疗中得到改善 受伤后六个月，该组相对于对照组人群。 这 次要假设包括各种神经心理学 测量，确定低温是否会降低死亡率 严重脑外伤后三个月内以及是否 低温可降低创伤后和特发性的发生率 癫痫发作相对于未经治疗的患者。 样本量为 250 个 这两次武装审判中的群体将根据以下情况进行分层： 复苏后运动功能。 预计该研究 应该需要三年多的时间才能完成。此次修订 该提案于 1993 年 10 月进行了初步审查。 众所周知，急性脑损伤会降低神经功能 在各种情况下都会造成损害，调查人员已经 进行了两项表面诱导中度低温的 II 期试验。 这些研究表明， 患者在三个月内取得良好的结果，没有出现严重的症状 体温过低相关的并发症，尽管这些研究规模并不大 足以显示显着差异。 这些试点研究确实 证明所提议程序的可行性，以及所有 中心是紧急医疗服务系统的一部分，具有快速 运输时间。 该研究旨在能够检测到变化 百分之十的患者恢复良好，而不是恢复不佳。 外伤性脑损伤通常是一个特别严重的问题，因为 受害者很年轻并且以前很健康。 受伤是意料之外的， 受害者可能会存活很长一段时间，因为他们的一般情况 医疗卫生状况良好。 但由于精神上的缺陷，他们 往往无法成为社会的富有成效的成员，并且经常 给他们的家庭带来严重的经济负担。这当然是在 除了这种毁灭性的严重情感后果 损失。 研究人员引用了多种动物模型表明 急性脑损伤发生后迅速引起体温过低 减少神经损伤。 虽然减少伤害的机制 体温过低的原因尚未得到充分了解，详细 这个过程的发病机制不是本提议的主要焦点 调查。 二期试验的初步结果相当不错 有希望的，并且拟议的研究很可能将在以下方面发挥关键作用： 证明临床实用治疗方式的有效性。 如果 这项研究表明低温会导致大脑功能显着下降 损害，很可能在照顾大量人员方面发生重大变化 创伤患者将随之而来。