Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury

NCT ID: NCT01852773

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-12-31

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.

Conditions

Blunt Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Blunt Aortic Injury Patients

Trauma patients with blunt aortic injury. This Cohort of trauma patients will require management with one of two interventions. They will require either; Open repair of thoracic aorta injury (Intervention #1) or TEVAR (Intervention #2). As of yet the short term and long term outcomes of these two treatments have not been directly compared.

Open repair of thoracic aorta injury

Intervention Type: PROCEDURE

open surgical management of aortic injury

TEVAR

Intervention Type: PROCEDURE

Use of endovascular (minimally invasive) techniques for repair of aortic injury

Interventions

Open repair of thoracic aorta injury

open surgical management of aortic injury

Intervention Type: PROCEDURE

TEVAR

Use of endovascular (minimally invasive) techniques for repair of aortic injury

Intervention Type: PROCEDURE

Other Intervention Names

Open chest repair of injured aorta; Thoracic endovascular aortic repair

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of blunt aortic injury (BAI)

Exclusion Criteria

• Clinical diagnosis of penetrating aortic injury

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Trauma Association

OTHER

Sponsor Role: collaborator

Scripps Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven R Shackford, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Mercy Hospital, Division of Trauma Surgery

Locations

Scripps Mercy Hospital

San Diego, California, United States

Countries

United States

Other Identifiers

IRB-11-5736

Identifier Type: -

Identifier Source: org_study_id