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Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury (TEVAR)

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ClinicalTrials.gov Identifier: NCT01852773
Recruitment Status : Withdrawn (Only observational retrospective study performed. No enrollees collected.)
First Posted : May 14, 2013
Last Update Posted : September 13, 2016
Sponsor:
Collaborator:
Western Trauma Association
Information provided by (Responsible Party):
Scripps Health

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?

Condition or disease Intervention/treatment
Blunt Injury Procedure: Open repair of thoracic aorta injury Procedure: TEVAR

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury
Study Start Date : May 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Group/Cohort Intervention/treatment
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.
Procedure: Open repair of thoracic aorta injury
open surgical management of aortic injury
Other Name: Open chest repair of injured aorta

Procedure: TEVAR
Use of endovascular (minimally invasive) techniques for repair of aortic injury
Other Name: Thoracic endovascular aortic repair




Primary Outcome Measures :
  1. Short-Term Mortality [ Time Frame: 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.


Secondary Outcome Measures :
  1. Short-Term Treatment-Associated Complications [ Time Frame: During the index hospitalization, an expected average of 30 days from time of injury ]
    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.

  2. Long-Term Treatment-Associated Complications [ Time Frame: Up to 5 years following discharge ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Trauma patients with blunt aortic injury (BAI)
Criteria

Inclusion Criteria:

  • Clinical diagnosis of blunt aortic injury (BAI)

Exclusion Criteria:

  • Clinical diagnosis of penetrating aortic injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852773


Locations
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United States, California
Scripps Mercy Hospital
San Diego, California, United States, 92103
Sponsors and Collaborators
Scripps Health
Western Trauma Association
Investigators
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Principal Investigator: Steven R Shackford, MD Scripps Mercy Hospital, Division of Trauma Surgery
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Responsible Party: Scripps Health
ClinicalTrials.gov Identifier: NCT01852773    
Other Study ID Numbers: IRB-11-5736
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Scripps Health:
blunt
injury
aorta
endovascular
Additional relevant MeSH terms:
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Wounds, Nonpenetrating
Wounds and Injuries