Clinical trial NCT01852773: Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury
Official title: Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Blunt Injury
Keywords: blunt
injury
aorta
endovascular
Lead sponsor: Scripps Health
Sponsor class: OTHER
Collaborators: name: Western Trauma Association
First posted: 2013-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trauma patients with blunt aortic injury (BAI)

Brief summary: 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?

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of blunt aortic injury (BAI)

Exclusion Criteria:

* Clinical diagnosis of penetrating aortic injury

Primary outcomes:
measure: Short-Term Mortality
timeFrame: During the index hospitalization, an expected average of 30 days from time of injury
Secondary outcomes:
measure: Short-Term Treatment-Associated Complications
timeFrame: During the index hospitalization, an expected average of 30 days from time of injury
measure: Long-Term Treatment-Associated Complications
timeFrame: Up to 5 years following discharge
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Mercy Hospital
state: California
Study officials:
affiliation: Scripps Mercy Hospital, Division of Trauma Surgery
name: Steven R Shackford, MD
role: PRINCIPAL_INVESTIGATOR
References: