National Acute Brain Injury Study: Hypothermia II

国家急性脑损伤研究：体温过低 II

• 批准号: 7285262
• 负责人: Guy L. Clifton
• 金额: $ 174.33万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-08-15 至 2008-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7285262
• 关键词: Acute Brain Injuries; Admission activity; Age; Brain Injuries; Complication; Confounding Factors (Epidemiology); Data; Enrollment; Glasgow Outcome Scale; Hour; Injury; Intracranial Hypertension; Maintenance; Neuropsychological Tests; Outcome; Outcome Measure; Patients; Phase III Clinical Trials; Population; Randomized; Rate; Recovery; Sample Size; Score; Standards of Weights and Measures; Subgroup; Surface; Temperature; Testing; Therapeutic; Toxic effect; base; disability; improved; medical complication; natural hypothermia; prospective; treatment effect

DESCRIPTION (provided by applicant): This proposed project, the National Acute Brain Injury Study: Hypothermia II (NABIS:H In will be a multi-center, prospective, randomized Phase III clinical trial in which standard management at hypothermia (33 degrees C) for 48 hours is tested against standard management at normothermia in patients with severe brain injury (GCS<8), age 16-45 years, and with admission temperature less than or equal to 35 degrees C . The primary outcome measure will be the dichotomized Glasgow Outcome Scale at 6 months after injury (Good Recovery/Moderate Disability vs. Severe Disability/Vegetative/Dead). The sample size of 220 patients will detect an absolute difference of 17% in the percentage of poor outcomes in the two groups at a power of 80%. The selection of this population was based on findings from the original National Acute Brain Injury Study: Hypothermia (NABIS:H I). In that study, with a sample size of 392, hypothermia was induced beginning <6 hours after injury, reaching 33 degrees C by 8.4 + or - 3 hours after injury, and maintaining hypothermia for 48 hours. The null hypothesis was confirmed, with no difference in the percentage of patients making a poor recovery (Severe Disability, Vegetative, Dead) at 6 months after injury (Hypothermia 57%, Normothermia 57%, NS). In 52 patients age >45 years, there were more poor outcomes in the hypothermia group (Hypothermia 89%, Normothermia 69%, p=0.08) due to increased medical complications. However, in 81 patients (22% of 366 patients with complete data) who were age 16-45 years with admission temperature less than or equal to 35 C, maintenance of hypothermia was associated with a marked decrease in the percentage of poor outcomes (Hypothermia, 52%, Normothermia 76%, p=0.02) with no difference in complication rates. The effect was found in all of the 4 high-enrollment centers, and there were no confounding variables that could have explained the difference in outcomes. The entire treatment effect in this subgroup was to shift patients from Severe Disability (poor outcome) to Moderate Disability (good outcome). We believe that the finding is related to a very short treatment window for hypothermia induction. The proposed study prospectively tests whether maintenance of hypothermia present on admission results in better outcome than current management.

描述（由申请人提供）：该提议的项目，国家急性 脑损伤研究：体温过低II（NABIS：H IN将是多中心， 标准管理 在体温过低（33度c）中，对标准管理进行了48小时的测试 严重脑损伤患者（GCS <8），年龄16-45岁的患者及其常渗症和 入院温度小于或等于35度c。主要结局措施将是受伤后6个月后的二分法格拉斯哥结局量表（良好 恢复/中度残疾与严重的残疾/植物/死亡）。样本 220名患者的大小将检测到17％的绝对差异 两组的不良结局的百分比为80％。选择 这个人群的基于原始国家急性大脑的发现 损伤研究：体温过低（NABIS：H I）。在该研究中，样本量为 392，受伤后诱导体温过低，达到33度C 8.4 +或 - 受伤后3小时，并保持体温过低48小时。这 零假设已得到证实，患者百分比没有差异 在6个月后的6个月后，使恢复不良（严重的残疾，营养，死亡） 损伤（体温过低57％，Normothermia 57％，NS）。在52名患者> 45岁的患者中， 体温过低组的预后较差（体温过低89％， 由于医疗并发症的增加，Normothermia 69％，p = 0.08）。但是，在 81例16-45岁的患者（366名具有完整数据的患者中有22％） 入院温度小于或等于35 C，维护 低温与贫困百分比显着下降有关 结局（体温过低，52％，Normothermia 76％，p = 0.02），没有差异 并发症率。在所有4个高注册中都发现了效果 中心，没有任何混杂变量可以解释 结果的差异。该亚组的整个治疗效果是 将患者从严重的残疾（预后不良）转移到中度残疾 （良好的结果）。我们认为这一发现与很短 低温诱导的治疗窗口。拟议的研究前瞻性 测试在入院中的体温过低是否会导致更好 结果比当前管理。