Blunt Traumatic Aortic InjuryBTAINCT07490015
Blunt Traumatic Aortic Injury
An observational study of Blunt Traumatic Aortic Injury and BTAI, run by Methodist Health System at 1 site in United States.
Trial summary
This is a retrospective and prospective multi-center observational study of the management and outcomes of BTAI. This study will include patients who meet the registry inclusion criteria as documented in EPIC and chart review will start from January 2019 and December 2028. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blunt Traumatic Aortic Injury, BTAI
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to Dec 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: • ≥ 18 years old
Who may be able to join
- ≥ 18 years old
- Computed tomography (CT)/CT angiography, angiographic, or intravascular ultrasound diagnosis of injury of the thoracic aorta
Who cannot join
- < 18 years old
- Patients without a diagnosis of vascular injury
- Patients who were initially treated for their vascular injury at a prior medical facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: Aortic Trauma Foundation Prospective Blunt Thoracic Aortic Injury Registry
This is a retrospective and prospective multi-center observational study of the management and outcomes of BTAI. This study will include patients who meet the registry inclusion criteria as documented in EPIC and chart review will start from January 2019 and December 2028. Data and endpoints will be observational and involve no prescribed therapeutic interventions or alterations in patient care. Institutions and providers will conduct normal diagnosis, management, and surveillance procedures without interference of this study.
Read the detailed description
This is a retrospective and prospective multi-center observational study of the management and outcomes of BTAI. This study will include patients who meet the registry inclusion criteria as documented in EPIC and chart review will start from January 2019 and December 2028. Data and endpoints will be observational and involve no prescribed therapeutic interventions or alterations in patient care. Institutions and providers will conduct normal diagnosis, management, and surveillance procedures without interference of this study.
- Conditions
- Blunt Traumatic Aortic Injury, BTAI
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to establish a database of information that will allow the presentation, diagnosis, management, and outcomes of BTAI to be analyzed.
Measured: January 2019 and December 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start8 Apr 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blunt Traumatic Aortic 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490015
- Sponsor's protocol ID
- 002.TRA.2024.D
- Acronym
- BTAI
- Status last verified
- Jun 2026
- First submitted
- 18 Mar 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Trauma Foundation Prospective Blunt Thoracic Aortic Injury Registry
- ClinicalTrials.gov ID
- NCT07490015
- Acronym / sponsor ID
- BTAI / 002.TRA.2024.D
- Conditions
- Blunt Traumatic Aortic Injury, BTAI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Mar 2026 (actual)
- 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 is a retrospective and prospective multi-center observational study of the management and outcomes of BTAI. This study will include patients who meet the registry inclusion criteria as documented in EPIC and chart review will start from January 2019 and December 2028. Data and endpoints will be observational and involve no prescribed therapeutic interventions or alterations in patient care. Institutions and providers will conduct normal diagnosis, management, and surveillance procedures without interference of this study.
Detailed description
This is a retrospective and prospective multi-center observational study of the management and outcomes of BTAI. This study will include patients who meet the registry inclusion criteria as documented in EPIC and chart review will start from January 2019 and December 2028. Data and endpoints will be observational and involve no prescribed therapeutic interventions or alterations in patient care. Institutions and providers will conduct normal diagnosis, management, and surveillance procedures without interference of this study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- • ≥ 18 years old
Key inclusion criteria (2 listed)
- ≥ 18 years old
- Computed tomography (CT)/CT angiography, angiographic, or intravascular ultrasound diagnosis of injury of the thoracic aorta
Key exclusion criteria (3 listed)
- < 18 years old
- Patients without a diagnosis of vascular injury
- Patients who were initially treated for their vascular injury at a prior medical facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary objective of this study is to establish a database of information that will allow the presentation, diagnosis, management, and outcomes of BTAI to be analyzed.
Time frame: January 2019 and December 2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Traumatic Aortic Injury and BTAI, run by Methodist Health System 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The primary objective of this study is to establish a database of information that will allow the presentation, diagnosis, management, and outcomes of BTAI to be analyzed. (time frame: January 2019 and December 2028). 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 25 Jun 2026.