Early Determination of Neurological Prognosis in ICU Patients With Severe Traumatic Brain Injury: The TBI-Prognosis Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 315
- 试验地点
- 17
- 主要终点
- Glasgow Outcome Scale Extended
研究概览
简要总结
Severe traumatic brain injury (TBI) is the leading cause of death and disability among people under 45 years of age and a major public health problem. Although management of severe TBI patients has gradually improved with the establishment of intensive care units (ICU) and the development of practice guidelines, mortality is still high - ranging from 30 to 50% - with 30% of survivors suffering from severe neurological sequelae such as neurovegetative states. Families and medical teams are frequently called upon to determine reasonable and appropriate goals of care for brain injured patients. They may have to consider high intensity of care, but also the withdrawal of life-sustaining therapies in accordance with patient wishes. Physicians involved in the care of severe traumatic brain injury have expressed serious concerns about hasty decisions made in the absence of appropriate evidence of unfavourable prognosis. The purpose of the TBI-Prognosis study is to develop a prognostic model by using a multimodal approach of different prognostic indicators and their evolution over time in the acute phase of care. The results of this study will provide better objective information that will facilitate the shared-decision making-process with families and relatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥ 18 years) with severe blunt TBI admitted to the ICU
- •All patients with a GCS ≤ 8 after initial resuscitation
排除标准
- •Anticipated being on mechanical ventilation for < 48 hour period due to an altered level of consciousness related to the TBI plus another potentially reversible factor (i.e. drugs, substance abuse, excessive sedation, etc.).
- •Solid malignancy with a life expectation <12 months
- •Liver cirrhosis Child C
- •Chronic heart failure (NYHA class IV)
- •End-stage chronic respiratory disease (O2 dependent)
- •End-stage renal disease (initiated or expectant chronic dialysis or to be expected)
- •Previous neurologic disorder with abnormal findings (such as a mass lesion) on radiological imaging (CT-scan, MRI) or electrophysiological tests (EEG, SSEP) (such as previous uncontrolled epilepsy, significant stroke, previous or acute concomitant spinal cord injury, etc)
- •Patients with no fixed address will be excluded because of the difficult follow-up
- •Physician refusal
结局指标
主要结局
Glasgow Outcome Scale Extended
时间窗: 12 months
次要结局
- EuroQuol - EQ-5D-5L(12 months)
- Glasgow Outcome Scale Extended(6 months)
研究者
Alexis Turgeon
MD MSc FRCPC
CHU de Quebec-Universite Laval
