Spreading Depressions as Secondary Insults After Traumatic Injury to the Human Brain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 5
- 主要终点
- Incidence of spreading depressions as assessed by continuous electrocorticography for 3-7 days after surgery. Primary neurologic outcome will be measured by the Glasgow Outcome Score - Extended.
研究概览
简要总结
Since the primary damage from traumatic brain injury (TBI) is irreversible, the focus of medical management of TBI is preventing secondary injury that can be life-threatening and worsen patient outcome. Insight into the pathologic mechanisms of secondary injury, which are largely unknown, is required for developing better treatments.
In preliminary studies, the investigators have found that a pathologic brain activity, known as spreading depression, recurs in a large number of TBI patients in the first week after injury. Spreading depressions are short-circuits of brain function that arise spontaneously from an injury and spread repeatedly as waves into neighboring brain tissue. Animal research has shown that spreading depressions can cause secondary injury to the brain.
The primary objective of this observational study is to determine whether the occurrence or severity of spreading depression is related to worse neurologic recovery from TBI. Results from the study will determine whether monitoring of spreading depression should be used as a guide or target for improved medical management of the TBI patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •diagnosis of TBI
- •craniotomy performed as per required treatment of TBI
- •craniotomy surgery < 7 days after TBI
- •GCS<13 at time of decision for surgery
- •expected neuromonitoring for >72 hr
排除标准
- •any failure to meet above criteria
- •pregnancy
- •GCS 3 with fixed, dilated pupils
结局指标
主要结局
Incidence of spreading depressions as assessed by continuous electrocorticography for 3-7 days after surgery. Primary neurologic outcome will be measured by the Glasgow Outcome Score - Extended.
时间窗: Six months post-TBI.
次要结局
- Post-traumatic epilepsy questionnaire.(6, 12, and 24 months post-TBI)
研究者
Jed Hartings
Associate Research Professor
University of Cincinnati
