Blunt InjuryTEVARNCT01852773
Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury
An observational study of Blunt Injury, run by Scripps Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blunt Injury
- What is being tested?
- Open repair of thoracic aorta injury and TEVAR
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Trauma patients with blunt aortic injury (BAI)
Who may be able to join
- Clinical diagnosis of blunt aortic injury (BAI)
Who cannot join
- Clinical diagnosis of penetrating aortic injury
Trial locations and contacts
1 site in 1 country.
About this study
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:
- What clinical variables affect short-term mortality and neurologic outcome?
- What are the long-term treatment-associated complications of open repair and TEVAR?
- In patients with a similar injury and physiologic profile, is there a survival advantage resulting from the type of operative treatment?
Read the 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:
- What clinical variables affect short-term mortality and neurologic outcome?
- What are the long-term treatment-associated complications of open repair and TEVAR?
- 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
- Being tested
- Open repair of thoracic aorta injury, TEVAR
- Keywords
- blunt, injury, aorta, endovascular
- Medical subject headings
- Wounds, Nonpenetrating, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open repair of thoracic aorta injuryProcedure or surgery
Also called Open chest repair of injured aorta
open surgical management of aortic injury
TEVARProcedure or surgery
Also called Thoracic endovascular aortic repair
Use of endovascular (minimally invasive) techniques for repair of aortic injury
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Open repair of thoracic aorta injury; Procedure: TEVAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the index hospitalization, an expected average of 30 days from time of injury
Secondary outcomes (2)
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.
Measured: During the index hospitalization, an expected average of 30 days from time of injury
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.
Measured: Up to 5 years following discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Only observational retrospective study performed. No enrollees collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blunt InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Collaborators
- Western Trauma Association
- Responsible party
- Sponsor
- Investigators
- Steven R Shackford, MD, Principal investigator, Scripps Mercy Hospital, Division of Trauma Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852773
- Sponsor's protocol ID
- IRB-11-5736
- Acronym
- TEVAR
- Status last verified
- Sep 2016
- First submitted
- 21 Mar 2013
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Endovascular Repair Versus Open Surgery for Blunt Injury
- ClinicalTrials.gov ID
- NCT01852773
- Acronym / sponsor ID
- TEVAR / IRB-11-5736
- Conditions
- Blunt Injury
- Keywords
- blunt, injury, aorta, endovascular
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Only observational retrospective study performed. No enrollees collected.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Collaborators
- Western Trauma Association
- Study start
- May 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What clinical variables affect short-term mortality and neurologic outcome?
- What are the long-term treatment-associated complications of open repair and TEVAR?
- 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:
- What clinical variables affect short-term mortality and neurologic outcome?
- What are the long-term treatment-associated complications of open repair and TEVAR?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blunt Aortic Injury Patients | – | Procedure: Open repair of thoracic aorta injury, Procedure: TEVARTrauma 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trauma patients with blunt aortic injury (BAI)
Key inclusion criteria (1 listed)
- Clinical diagnosis of blunt aortic injury (BAI)
Key exclusion criteria (1 listed)
- Clinical diagnosis of penetrating aortic injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open repair of thoracic aorta injuryAlso: Open chest repair of injured aortaopen surgical management of aortic injury | Procedure or surgery | Blunt Aortic Injury Patients |
| TEVARAlso: Thoracic endovascular aortic repairUse of endovascular (minimally invasive) techniques for repair of aortic injury | Procedure or surgery | Blunt Aortic Injury Patients |
Primary outcome
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.
2 secondary outcomes
Short-Term Treatment-Associated Complications
Time frame: During the index hospitalization, an expected average of 30 days from time of injury
Long-Term Treatment-Associated Complications
Time frame: Up to 5 years following discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Shackford, MD principal investigator
Scripps Mercy Hospital, Division of Trauma Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blunt Injury, run by Scripps Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-Term Mortality (time frame: During the index hospitalization, an expected average of 30 days from time of injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.