Multicenter trial of early hypothermia in severe brain injury.
Multicenter trial of early hypothermia in severe brain injury.
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DOI：
10.1089/neu.2008.0556
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发表时间：
2009-03
影响因子：
4.2
通讯作者：
Okonkwo D
中科院分区：
文献类型：
--
作者：
Clifton GL;Drever P;Valadka A;Zygun D;Okonkwo D
北美脑损伤研究：低温IIR（NABIS：H IIR）是一项随机临床试验，旨在招募240名16至45岁的严重脑损伤患者。主要结果测量是损伤后6个月的二分格拉斯哥结果量表（GOS）。该研究有能力检测到具有良好结局的患者百分比的17.5%的绝对差异，具有80%的把握度。所有患者均通过放弃知情同意进行随机化，除非家属立即可用。受伤后2.5小时内入组。患者可由研究附属的急诊医疗服务人员或患者到达急诊科时的研究人员在现场入组。不遵守命令且没有排除标准的患者以及入组研究的低温组的患者通过静脉内施用多达2升的冷冻晶体尽快冷却至35°C。将符合方案第二阶段标准的患者（主要是复苏后GCS 3-8，无低血压和严重相关损伤）冷却至33°C。入组常温组的患者在常温下接受标准管理。截至2007年12月，74名患者被随机分配到该方案的第二阶段。低温组患者在损伤后2.7 ± 1.1（SD）h达到35°C，在损伤后4.4 ± 1.5 h达到33°C。
The North American Brain Injury Study: Hypothermia IIR (NABIS:H IIR) is a randomized clinical trial designed to enroll 240 patients with severe brain injury between the ages of 16 and 45 years. The primary outcome measure is the dichotomized Glasgow Outcome Scale (GOS) at 6 months after injury. The study has the power to detect a 17.5% absolute difference in the percentage of patients with a good outcome with a power of 80%. All patients are randomized by waiver of consent unless family is immediately available. Enrollment is within 2.5 h of injury. Patients may be enrolled in the field by emergency medical services personnel affiliated with the study or by study personnel when the patient arrives at the emergency department. Patients who do not follow commands and have no exclusion criteria and who are enrolled in the hypothermia arm of the study are cooled to 35°C as rapidly as possible by intravenous administration of up to 2 liters of chilled crystalloid. Those patients who meet the criteria for the second phase of the protocol (primarily a post-resuscitation GCS 3–8 without hypotension and without severe associated injuries) are cooled to 33°C. Patients enrolled in the normothermia arm receive standard management at normothermia. As of December 2007, 74 patients had been randomized into phase II of the protocol. Patients in the hypothermia arm reached 35°C in 2.7 ± 1.1 (SD) h after injury and reached 33°C at 4.4 ± 1.5 h after injury.