Early decompressive craniectomy for patients with severe traumatic brain injury and refractory intracranial hypertension - A pilot randomized trial
Early decompressive craniectomy for patients with severe traumatic brain injury and refractory intracranial hypertension - A pilot randomized trial
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DOI：
10.1016/j.jcrc.2007.05.002
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发表时间：
2008-09-01
影响因子：
3.7
通讯作者：
Kossmann, Thomas
中科院分区：
文献类型：
--
作者：
Cooper, D. James;Rosenfeld, Jeffrey V.;Kossmann, Thomas
目的：本研究的目的是在弥漫性创伤性脑损伤（TBI）和难治性颅内高压患者进行减压颅骨切除术的III期随机试验的前期研究中测试可行性并评估潜在的招募率。材料与方法：制定了研究方案，确定了纳入和排除标准，并建立了标准化的手术技术。损伤后6个月，通过一份经过验证的结构化问卷和一名训练有素的评估员对治疗组进行神经系统预后评估。结果：在澳大利亚墨尔本一级创伤中心进行的为期8个月的试点研究中，对69名重症TBI患者进行了纳入评估。6例患者符合条件，5例（8%）随机分组。损伤后6个月，100%的患者接受结果评估。多中心减压颅骨切除术研究方案的关键改进是通过试点研究实现的。结论：在严重TBI合并难治性颅内高压的患者中，神经系统预后良好（独立生活）的频率较低，与预测值（40%有利）相似。未来一项涉及IS神经创伤中心的多中心III期试验，保守的招募率仅为先导研究的25%，至少需要5年才能达到210例患者的样本量。与澳大利亚和新西兰以外国家的神经创伤中心合作，这样的三期试验才能取得成功。(c) 2008爱思唯尔公司版权所有。
Purpose: The aims of this study were to test the feasibility and to assess potential recruitment rates in a pilot study preliminary to a phase III randomized trial of decompressive craniectomy surgery in patients with diffuse traumatic brain injury (TBI) and refractory intracranial hypertension.Materials and Methods:. A Study protocol was developed, inclusion and exclusion criteria were defined, and a standardized surgical technique was established. Neurologic outcomes were assessed 6 months after injury with a validated, structured questionnaire and a single trained assessor blind to treatment group.Results: During the 8-month pilot study at a level 1 trauma center in Melbourne, Australia, 69 intensive care patients with severe TBI were assessed for inclusion. Six patients were eligible, and 5 (8%) were randomized. Six months after injury, 100% of patients received outcome assessments. Key improvements to the multicenter Decompressive Craniectomy study protocol were enabled by the pilot study.Conclusions: In patients with severe TBI and refractory intracranial hypertension, the frequency of favorable neurologic outcomes (independent living) was low and similar to predicted values (40% favorable). A future multicenter phase III trial involving IS neurotrauma centers with most sites conservatively recruiting at just 25% of the pilot study rate would require at least 5 years to achieve an estimated 210-patient sample size. Collaboration With neurotrauma centers in countries other than Australia and New Zealand would be required for such a phase III trial to be successful. (c) 2008 Elsevier Inc. All rights reserved.