Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Short-Term Mortality
研究概览
简要总结
This study aims to increase understanding of the short-term and long-term outcome of blunt aortic injury (BAI) and to discern if there is an advantage resulting from the type of operative treatment used to manage it, either the classic open surgical repair or a newer technique known as thoracic endovascular repair (TEVAR). Specifically, this study will answer the following questions regarding patients suffering BAI:
- What clinical variables affect short-term mortality and neurologic outcome?
- What are the long-term treatment-associated complications of open repair and TEVAR?
- In patients with a similar injury and physiologic profile, is there a survival advantage resulting from the type of operative treatment?
详细描述
Blunt aortic injury (BAI) is responsible for 16% of traffic fatalities. Historically, about 80% of these deaths occur at the scene and 20% are transported to the hospital. With the development of systems of trauma care and other advances, it is likely that more patients with BAI will arrive alive at trauma centers.
Patients with BAI who arrive at the hospital can be treated with either classic open surgery or with endovascular techniques. A relatively new endovascular technique, thoracic endovascular repair (TEVAR), has been recommended by the Society of Vascular Surgery (SVS) as the procedure of choice for BAI. However, the data on which this was based was described as "very low quality evidence" (Grade 2, C), i.e., no better than expert opinion. It is important to note that the committee responsible for the recommendation of the SVS consisted of vascular surgeons, without input from trauma surgeons who are primarily responsible for the management of the trauma patient with BAI. This omission may have biased the literature review in favor of TEVAR because there was inadequate data in the published research to account for disparities of injury severity and physiologic compromise, both of which significantly impact outcome.
The investigators reviewed the recent literature on the management of BAI to determine if sufficient data exists to perform an "apples to apples" comparison between TEVAR and classic open surgery. The investigators believe that sufficient clinical equipoise has not been reached such that a prospective, randomized clinical trial could be undertaken.
Therefore, the investigators aim to conduct a multicenter 5-year combined historical cohort and concurrent cohort observational study of the short-term and long-term outcome of BAI. Such a study would answer the following clinically relevant questions in patients suffering BAI:
- What clinical variables affect short-term mortality and neurologic outcome?
- What are the long-term treatment-associated complications of open repair and TEVAR?
- In patients with a similar injury and physiologic profile, is there a survival advantage resulting from the type of operative treatment?
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of blunt aortic injury (BAI)
排除标准
- •Clinical diagnosis of penetrating aortic injury
结局指标
主要结局
Short-Term Mortality
时间窗: During the index hospitalization, an expected average of 30 days from time of injury
Cause of death during the index hospitalization (prior to discharge, averaging less than 30 days from the time of injury) will be assessed, as measured by death certificate and autopsy or, if no autopsy, morbidity and mortality review findings. Care withdrawn at request of family will also be noted. Final adjudication of mortality (preventable, non-preventable, or possibly preventable)will be gathered.
次要结局
- Short-Term Treatment-Associated Complications(During the index hospitalization, an expected average of 30 days from time of injury)
- Long-Term Treatment-Associated Complications(Up to 5 years following discharge)