Cooper D James, Rosenfeld Jeffrey V, Murray Lynnette, Wolfe Rory, Ponsford Jennie, Davies Andrew, D'Urso Paul, Pellegrino Vincent, Malham Gregory, Kossmann Thomas
Department of Intensive Care, Alfred Hospital, Monash University, Melbourne 3004, Australia.
J Crit Care. 2008 Sep;23(3):387-93. doi: 10.1016/j.jcrc.2007.05.002. Epub 2007 Dec 11.
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.
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.
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.
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 18 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.
本研究旨在测试可行性，并评估在一项针对弥漫性创伤性脑损伤（TBI）和难治性颅内高压患者的减压颅骨切除术III期随机试验之前的试点研究中的潜在招募率。
制定了研究方案，定义了纳入和排除标准，并建立了标准化手术技术。在受伤6个月后，使用经过验证的结构化问卷和对治疗组不知情的单一训练有素的评估者评估神经学结果。
在澳大利亚墨尔本一家一级创伤中心进行的为期8个月的试点研究中，对69名患有严重TBI的重症监护患者进行了纳入评估。6名患者符合条件，5名（8%）被随机分组。受伤6个月后，100%的患者接受了结果评估。试点研究促成了多中心减压颅骨切除术研究方案的关键改进。
在患有严重TBI和难治性颅内高压的患者中，良好神经学结果（独立生活）的频率较低，与预测值（40%良好）相似。未来一项涉及18个神经创伤中心的III期试验，大多数中心保守地以试点研究率的25%进行招募，将需要至少5年时间才能达到估计的210名患者的样本量。要使这样的III期试验成功，需要与澳大利亚和新西兰以外国家的神经创伤中心合作。
