Multi-centre Prospective Randomised Trial of Early Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Proportion (%) of favourable outcomes (GOSE 5-8)
研究概览
简要总结
This is a multi-centre randomised trial to evaluate the effect of early decompressive craniectomy on neurological function in patients with severe traumatic brain injury.
The primary outcome is neurological function measured at 6 months post injury using the Glasgow Outcome Score. Neurological function is qualified as proportion of favourable outcomes (Glasgow Outcome Score Extended [GOSE] grades 5-8).
详细描述
Comparison After meeting the entry criteria, and the patient will be randomised to either early DC surgery (see below) or best current conventional management. Those randomised to surgery will have the operation done within 6 hours of randomisation. They will then return to the ICU and be managed thereafter in the same way as the conventional arm. Patients in the conventional arm will have all the usual therapies for increasing ICP optimised again. They then may have cooling to 35.0C or thiopentone bolus or thiopentone coma. These options are at the clinicians discretion. Late DC surgery in the control patients is discouraged however it may be done at the neurosurgeons discretion. These patients will be included in the intention to treat analysis.
Surgical Technique The technique described by Polin will be used. The operation will comprise bi-frontal decompressive craniectomies with a single fronto-temporal bone flap extending across the midline. The temporalis muscles will be reflected inferiorly. Burr holes are located either side of the sagittal sinus at the posterior extent and bilaterally at the keyhole and at the root of the zygoma. This will create a large bifrontal craniectomy defect extending posteriorly to the coronal sutures. Bilateral large sub-temporal decompressions will be performed down to the skull base. The final bone cut is made along the supra-orbital ridges with an attempt to preserve the frontal sinus. Burr holes will be placed either side of the sagittal sinus inferiorly and the bone will be lifted out.
The dura will be opened in one of two alternative ways:
- The dura is opened with a cruciate incision bilaterally. OR
- A large L shaped incision with the lower corner of the L facing laterally. The advantage to this method is that the cerebral veins are not disturbed medially by this incision.
The dural opening should be covered with a dural or facial patch, so that the brain does not adhere to the scalp. Water tight dural closure is not necessarily aimed for. For patients receiving EVD monitoring, an ICP monitor with ventricular catheter (± optional PO2 and temperature monitor) may be placed prior to closure. Some patients will have been randomised to parenchymal catheter only. These patients will not have an EVD inserted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 15 - 60 years and within the first 72 hrs from time of injury
- •Severe diffuse Traumatic Brain Injury defined as:
- •GCS < 9 and CT scan* with any evidence of brain swelling CT brain scan (DII + some evidence of swelling or DIII or DIV) OR
- •GCS >8 before intubation and DIII or DIV CT brain scan (basal cistern compression ± midline shift)
- •ICP monitor in situ. EVD recommended.
- •"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 EVD venting) of >20mm Hg for more than 15 mins (continuously or cumulative over one hour).
排除标准
- •Intracranial haemorrhage > 3 cm diameter
- •Intracranial mixed haemorrhagic contusion >5cm in long axis
- •Previous craniectomy
- •EDH/SDH/ or large contusion requiring evacuation
- •EDH/SDH >0.5 cm thickness
- •Spinal cord injury
- •Penetrating brain injury
- •Arrest at scene
- •Unreactive pupils >4mm, and GCS=3
- •Neurosurgery contraindicated (eg: severe coagulopathy)
- •No chance of survival after consideration of CT and clinical findings following Neurosurgical consultant assessment (eg hemispheric infarct after carotid dissection).
结局指标
主要结局
Proportion (%) of favourable outcomes (GOSE 5-8)
时间窗: 6 month post injury
次要结局
- length of stay(ICU admisssion)
- Mean and maximum hourly intracranial pressure (ICP)(36hrs post randomisation)
- Favourable outcomes (GOSE)(12 months post injury)
- Mean GOSE using ordinal logistic regression(6 months and 12 months)
- Mortality(hospital, 6 months, 12 months)
- Brain metabolites using microdialysis (The Alfred Hospital only)(During monitoring phase)
研究者
Prof Jamie Cooper
Chief Investigator
National Trauma Research Institute