Very early hypothermia induction in patients with severe brain injury (the National Acute Brain Injury Study: Hypothermia II): a randomised trial.
Very early hypothermia induction in patients with severe brain injury (the National Acute Brain Injury Study: Hypothermia II): a randomised trial.
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DOI：
10.1016/s1474-4422(10)70300-8
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发表时间：
2011-02
期刊：
影响因子：
48
通讯作者：
Okonkwo, David O.
中科院分区：
文献类型：
--
作者：
Clifton, Guy L.;Valadka, Alex;Zygun, David;Coffey, Christopher S.;Drever, Pamala;Fourwinds, Sierra;Janis, L. Scott;Wilde, Elizabeth;Taylor, Pauline;Harshman, Kathy;Conley, Adam;Puccio, Ava;Levin, Harvey S.;McCauley, Stephen R.;Bucholz, Richard D.;Smith, Kenneth R.;Schmidt, John H.;Scott, James N.;Yonas, Howard;Okonkwo, David O.
在以往的试验中，亚低温治疗对重型脑损伤的效果不一致，这可能是因为亚低温在损伤后诱导得太晚。我们的目的是评估是否非常早期诱导低温改善严重脑损伤患者的预后。国家急性脑损伤研究：低温II（NABIS：H II）是一项随机、多中心的临床试验，在美国和加拿大的6个研究中心，在损伤后2.5小时内招募了严重脑损伤患者。年龄在16-45岁的非穿透性脑损伤患者，对指令无反应，通过随机数字发生器随机分配（1：1）至低温或常温。随机分配到低温组的患者被冷却到35°C，直到他们的创伤评估完成。没有第二组排除标准的患者冷却至33°C持续48小时，然后逐渐复温或在正常体温下治疗，这取决于他们的初始治疗分配。评估结局指标的研究者对治疗分配设盲。主要结局是6个月时的格拉斯哥结局量表评分。通过修改的意向治疗进行分析。该试验在ClinicalTrials.gov注册，NCT 00178711。从2005年12月至2009年6月，试验因无效而终止。随访时间为2006年6月至2009年12月。232名患者在伤后平均1.6小时（SD 0.5）开始随机分组：119名患者接受低温治疗，113名患者接受正常体温治疗。97名患者（低温组52名，常温组45名）不符合第二组排除标准中的任何一项。低温组52例患者达到35°C的平均时间为2.6 h（SD 1.2），达到33°C的平均时间为4.4 h（1.5）。低温组52例患者中有31例预后不良（严重残疾、植物人状态或死亡），常温组56例患者中有25例预后不良（相对危险度[RR] 1.08，95%CI 0.76 - 1.53; p= 0.67）。低温组有12名患者死亡，而常温组有8名患者死亡（RR 1.30，95% CI 0.58 - 2.52; p= 0.52）。这项试验没有证实低温作为严重创伤性脑损伤患者的主要神经保护策略的实用性。国家神经疾病和中风研究所。
The inconsistent effect of hypothermia treatment on severe brain injury in previous trials might be because hypothermia was induced too late after injury. We aimed to assess whether very early induction of hypothermia improves outcome in patients with severe brain injury. The National Acute Brain Injury Study: Hypothermia II (NABIS: H II) was a randomised, multicentre clinical trial of patients with severe brain injury who were enrolled within 2·5 h of injury at six sites in the USA and Canada. Patients with non-penetrating brain injury who were 16–45 years old and were not responsive to instructions were randomly assigned (1:1) by a random number generator to hypothermia or normothermia. Patients randomly assigned to hypothermia were cooled to 35°C until their trauma assessment was completed. Patients who had none of a second set of exclusion criteria were either cooled to 33°C for 48 h and then gradually rewarmed or treated at normothermia, depending upon their initial treatment assignment. Investigators who assessed the outcome measures were masked to treatment allocation. The primary outcome was the Glasgow outcome scale score at 6 months. Analysis was by modified intention to treat. This trial is registered with ClinicalTrials.gov, NCT00178711. Enrolment occurred from December, 2005, to June, 2009, when the trial was terminated for futility. Follow-up was from June, 2006, to December, 2009. 232 patients were initially randomised a mean of 1·6 h (SD 0·5) after injury: 119 to hypothermia and 113 to normothermia. 97 patients (52 in the hypothermia group and 45 in the normothermia group) did not meet any of the second set of exclusion criteria. The mean time to 35°C for the 52 patients in the hypothermia group was 2·6 h (SD 1·2) and to 33°C was 4·4 h (1·5). Outcome was poor (severe disability, vegetative state, or death) in 31 of 52 patients in the hypothermia group and 25 of 56 in the normothermia group (relative risk [RR] 1·08, 95% CI 0·76–1·53; p=0·67). 12 patients in the hypothermia group died compared with eight in the normothermia group (RR 1·30, 95% CI 0·58–2·52; p=0·52). This trial did not confirm the utility of hypothermia as a primary neuroprotective strategy in patients with severe traumatic brain injury. National Institute of Neurological Disorders and Stroke.