ISRCTN61037228已完成不适用
Multi-centre prospective randomised trial of early decompressive craniectomy in patients with severe traumatic brain injury
ational Trauma Research Institute, The Alfred Hospital (Australia)0 个研究点目标入组 165 人开始时间: 2005年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 15-60 years
- •2. First 72 hours from time of injury
- •3. Severe diffuse Traumatic Brain Injury defined as:
- •3.1. Glasgow Coma Score (GCS) <9 and computed tomography (CT) scan with any evidence of brain swelling. CT brain scan DII + some evidence of swelling or DIII or DIV
- •3.2. GCS >8 before intubation and DIII or DIV. CT brain scan basal cistern compression ± midline shift
- •4. Intracanial pressure (ICP) monitor in situ
- •5. 'Refractory ICP' despite best conventional management. Refractory ICP in this study will be defined as the spontaneous persistent increase in ICP despite optimal conventional ICU therapies (including intermittent external ventricular drain [EVD] venting) of >20 mm Hg for more than 15 mins (continuously or cumulative over one hour).
排除标准
- •1. Intracranial mass lesion (>3 cm diameter) and/or previous craniectomy
- •2. Extradural hematoma / subdural hematoma (EDH/SDH) requiring evacuation
- •3. EDH/SDH >0.5 cm thickness
- •4. Spinal cord injury
- •5. Penetrating brain injury
- •6. Arrest at scene
- •7. Unreactive pupils >4 mm and GCS = 3
- •8. Neurosurgery contraindicated
- •9. No chance of survival after consideration of CT and clinical findings, following Neurosurgical consultant assessment
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