Blunt Injury Clinical Trial
Official title:
Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury
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:
1. What clinical variables affect short-term mortality and neurologic outcome?
2. What are the long-term treatment-associated complications of open repair and TEVAR?
3. In patients with a similar injury and physiologic profile, is there a survival
advantage resulting from the type of operative treatment?
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:
1. What clinical variables affect short-term mortality and neurologic outcome?
2. What are the long-term treatment-associated complications of open repair and TEVAR?
3. In patients with a similar injury and physiologic profile, is there a survival
advantage resulting from the type of operative treatment?
The proposed study will be done by Scripps Mercy Hospital Trauma Service with the
participation of interested member trauma centers of the Multicenter Trials Group of the
Western Trauma Association.
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Observational Model: Cohort, Time Perspective: Prospective
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