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临床试验/NCT02452541
NCT02452541Unknown不适用

Early Determination of Neurological Prognosis in ICU Patients With Severe Traumatic Brain Injury: The TBI-Prognosis Multicenter Prospective Study

CHU de Quebec-Universite Laval17 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2013年4月1日最近更新:
适应症

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

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

发起方
CHU de Quebec-Universite Laval
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexis Turgeon

MD MSc FRCPC

CHU de Quebec-Universite Laval

研究点 (17)

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