Non-Interventional F-Two Isoprostane Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Levels of oxidant injury in cerebrospinal fluid following severe traumatic brain injury
研究概览
简要总结
Each year in the United States alone, 300,000 persons are hospitalized for traumatic brain injury, with approximately one quarter dying. Despite advances in aggressive neurosurgical interventions, intensive care monitoring and overall supportive management, many of those who do "survive" do not fully recover and are left with a varying degree of permanent disability. It is therefore imperative that new methods of early interventions be explored.
One possible road to effective therapy is to examine the timing of secondary injury via a biological marker, to help guide the timing of treatment directed specifically at early oxidant injury. A more thorough understanding of how quickly oxidant injury occurs will allow us to direct appropriate therapies targeted directly at oxidant injury within what is currently thought to be a very narrow window of opportunity for intervention, possibly peaking within the first two hours after the initial injury.
Potential participants include patients between the ages of 18 and 50 years who are admitted to Parkland Memorial Hospital with a diagnosis of severe traumatic brain injury. Blood, urine, and CSF (if patient requires a clinically indicated ventriculostomy) will be collected over the first 5 days post-injury. Clinically-relevant patient progress, clinically required interventions, neuro-imaging results, and demographics will be tracked while the patient is hospitalized, with final neurological outcome measured at 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated age of 18 - 50 years
- •Glasgow Come Scale (GCS) score of between 3 and 8 prior to intubation and/or sedation.
- •Systolic blood pressure of >90 mm Hg
- •Receiving medical treatment in the Emergency Department (ED) of Parkland Hospital, a Level I Trauma Center in Dallas, Texas
排除标准
- •Those in whom the time of injury is unknown
- •Those with any 2 readings of systolic blood pressure of <90 prior to enrollment
- •Those who are known to have legal Do Not Resuscitate (DNR) orders in place prior to enrollment.
- •Those receiving CPR prior to enrollment
- •Known incarcerated individuals
- •Pulse ox reading of < 90 prior to enrollment
- •Status epilepticus prior to enrollment
- •Penetrating head trauma
结局指标
主要结局
Levels of oxidant injury in cerebrospinal fluid following severe traumatic brain injury
时间窗: Up to 5 days
F2 Isoprostane levels in cerebrospinal fluid following severe traumatic brain injury
次要结局
未报告次要终点
研究者
Wigginton
Associate Professor
University of Texas Southwestern Medical Center
