Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury

Blunt Injury Clinical Trial

— TEVAR  

Official title:

Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01852773
• Other study ID #: IRB-11-5736
• Status: Withdrawn
• Phase: N/A
• First received: March 21, 2013
• Last updated: September 9, 2016
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: Scripps Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of blunt aortic injury (BAI)

Exclusion Criteria:

• Clinical diagnosis of penetrating aortic injury

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blunt Injury
• Wounds and Injuries
• Wounds, Nonpenetrating

Intervention

Procedure:
• Open repair of thoracic aorta injury
open surgical management of aortic injury
• TEVAR
Use of endovascular (minimally invasive) techniques for repair of aortic injury

Locations

Country	Name	City	State
United States	Scripps Mercy Hospital	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Health	Western Trauma Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-Term Mortality	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.	During the index hospitalization, an expected average of 30 days from time of injury	No
Secondary	Short-Term Treatment-Associated Complications	Complications during the index hospitalization (prior to discharge, averaging less than 30 days from time of injury) related specifically to TEVAR or to open repair will be gathered. TEVAR-specific complications to include: endoleak; endocollapse; migration; loss of apposition at proximal landing zone; access complications. Open repair-specific complications to include: VATS for retained hemothorax; empyema.	During the index hospitalization, an expected average of 30 days from time of injury	No
Secondary	Long-Term Treatment-Associated Complications	Complications during the 5-year follow-up period post-discharge, related specifically to TEVAR or to open repair will also be gathered. TEVAR-specific complications to include: endoleak; endocollapse; migration; loss of apposition at proximal landing zone; graft infection; wound infection. Open repair-specific complications to include: graft infection; pseudoaneurysm; wound infection.	Up to 5 years following discharge	No