Multi-centre randomised trial of early decompressive craniectomy in patients with severe traumatic brain injury

尽管有最佳的神经外科和重症监护治疗，但许多严重脑损伤的创伤患者（通常是年轻男性）的长期神经预后非常差。目前的知识表明，损伤后继发性脑损伤和神经预后不良的一个关键因素是脑肿胀和随后的脑压升高。目前控制脑压的重症监护治疗往往无效，只有20-30%的患者出现良好的神经系统预后。小型研究表明，一种称为减压颅骨切除术（DC）的外科手术可以降低这些患者的脑压并改善神经系统预后。DC包括暂时手术切除一块颅骨（在肿胀期间），并在肿胀消退时替换它。DC是在全身麻醉下对无意识患者进行的，目前偶尔使用，但由于研究不足，其益处存在争议。拟议的研究是一项多中心随机对照研究，在选择的严重头部损伤的无意识患者中，对当前最佳疗法加早期减压颅骨切除术与当前最佳疗法单独进行比较。研究结果是在损伤后6个月测量患者的神经功能。在早期DC成为澳大利亚的常规治疗之前，需要对这种类型进行研究。如果患者随机接受手术，其近亲将签署研究知情同意书，然后也将签署手术知情同意书。这项研究将在墨尔本的阿尔弗雷德医院-莫纳什大学进行，包括15个合作的ANZ神经创伤中心，为期3年。澳大利亚每年有200名患者属于这一类别，每年有40名患者的DC有可能增加良好的预后。这些严重残疾患者的终生费用为240万美元，因此可能会产生重大的经济和社会影响。

Despite optimal neurosurgical and intensive care therapy, many trauma patients with severe brain injury (typically young males) have very poor long term neurological outcomes. Current knowledge suggests that a key contributor to secondary brain damage which occurs after injury and to poor neurological outcomes is brain swelling and subsequent increase in brain pressure. Present intensive care therapies to control brain pressure are often not effective, and favourable neurological outcomes occur in only 20-30% of these patients. Small studies suggest that a surgical operation called decompressive craniectomy (DC) may decrease brain pressure and improve neurological outcomes in these patients. DC involves temporarily surgically removing a piece of skull bone (during the swelling period) and replacing it when the swelling has subsided. DC is done under general anaesthetic in unconscious patients and is used occasionally at present, although due to insufficient research the benefits are controversial. The proposed study is a multi-centre randomised controlled study of best current therapies plus early decompressive craniectomy vs best current therapies alone in selected unconscious patients with severe head injury. The study outcome is patient neurological function measured 6 months after the injury. A study of this type is required before early DC could become a routine therapy in Australia. Next of kin will sign informed consent for the study and then also for the surgery if patients are randomised to surgery. The study will be managed at the Alfred Hospital-Monash University in Melbourne and includes fifteen collaborating ANZ neurotrauma centres over 3.0 years. There are >200 patients in Australia annually in this category with potential for DC to increase favourable outcomes in >40 patients annually. Lifetime costs for these patients with severe disability are > $2.4 million, so there may be substantial economic and social impact.