Aortic OcclusionNCT05263765
Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery
An observational study of Aortic Occlusion, run by Methodist Health System at 1 site in United States.
Trial summary
Aortic occlusion (AO) for trauma has traditionally been accomplished by supra-diaphragmatic clamping of the descending thoracic aorta via emergent thoracotomy or as an initial step during laparotomy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Occlusion
- What is being tested?
- utilization of AO in the acute resuscitation of trauma and acute care surgery patients in shock.
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2022to 29 Dec 2024
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: • All adult (age ≥ 18 years) trauma and acute care surgery patients treated with resuscitative AO (via open or endovascular means) in the acute phases after injury
Who may be able to join
- All adult (age ≥ 18 years) trauma and acute care surgery patients treated with resuscitative AO (via open or endovascular means) in the acute phases after injury
- Transient or refractory hypotension (systolic blood pressure <90mmHg) with a positive abdominal focused abdominal sonography in trauma (FAST) scan, severe pelvic fracture(s), or neither with persistent hypotension without obvious source
- Chest x-ray without evidence of thoracic aortic injury
- Subject treatment includes internal aortic cross-clamp or would have likely benefited from an internal aortic cross-clamp
Who cannot join
- Subject < 18 years of age
- Prisoner
- Evidence of cardiac, thoracic aortic, or great vessel injury identified in primary survey, FAST scan, and/or x-rays
- Any open/exsanguinating upper extremity wound
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 Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA)
Aortic occlusion (AO) for trauma has traditionally been accomplished by supra-diaphragmatic clamping of the descending thoracic aorta via emergent thoracotomy or as an initial step during laparotomy.
Read the detailed description
An evolution in endovascular technologies, however, has provided additional means by which to achieve AO. Expanding experience with the utilization of balloon occlusion in the setting of abdominal aortic rupture due to chronic vascular disease has demonstrated the potential of these new technologies. Discussion of the employment of endovascular AO in the realm of trauma has led to the description of this approach and the demonstration of its effectiveness in animal models of severe hemorrhage.
The purpose of the present study is to prospectively examine the modern utilization of AO in the acute resuscitation of trauma and acute care surgery patients in shock.
- Conditions
- Aortic Occlusion
- Being tested
- utilization of AO in the acute resuscitation of trauma and acute care surgery patients in shock.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
utilization of AO in the acute resuscitation of trauma and acute care surgery patients in shock.Procedure or surgery
AO to facilitate the acute resuscitation of trauma and acute care surgery patients in shock.
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
Age in years
Measured: 01 July 2015 through 31st December 2024
Demographics- Gender
Male or Female
Measured: 01 July 2015 through 31st December 2024
Demographics-Height
Height measured in Inches
Measured: 01 July 2015 through 31st December 2024
Demographics- Weight
Weight measured in pounds
Measured: 01 July 2015 through 31st December 2024
Injury Data
Mechanism classification - Penetrating, Blunt or Non-trauma Hemorrhage
Measured: 01 July 2015 through 31st December 2024
Injury Mechanism Type
Gunshot wound, Motor vehicle accident, stab wound, fall
Measured: 01 July 2015 through 31st December 2024
Body Region
Head/Neck, Chest, Abdomen, pelvis or Extremities
Measured: 01 July 2015 through 31st December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start29 Dec 2022
- Primary completion29 Dec 2024 (estimated)
- Study completion29 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic OcclusionStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Conner McDaniel, M.D., Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263765
- Sponsor's protocol ID
- 063.TRA.2021.D
- Status last verified
- Mar 2024
- First submitted
- 3 Feb 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA)
- ClinicalTrials.gov ID
- NCT05263765
- Acronym / sponsor ID
- 063.TRA.2021.D
- Conditions
- Aortic Occlusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 29 Dec 2024 (estimated)
- Study completion
- 29 Dec 2024 (estimated)
- First posted
- 3 Mar 2022 (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.
Aortic occlusion (AO) for trauma has traditionally been accomplished by supra-diaphragmatic clamping of the descending thoracic aorta via emergent thoracotomy or as an initial step during laparotomy.
Detailed description
An evolution in endovascular technologies, however, has provided additional means by which to achieve AO. Expanding experience with the utilization of balloon occlusion in the setting of abdominal aortic rupture due to chronic vascular disease has demonstrated the potential of these new technologies. Discussion of the employment of endovascular AO in the realm of trauma has led to the description of this approach and the demonstration of its effectiveness in animal models of severe hemorrhage.
The purpose of the present study is to prospectively examine the modern utilization of AO in the acute resuscitation of trauma and acute care surgery patients in shock.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- • All adult (age ≥ 18 years) trauma and acute care surgery patients treated with resuscitative AO (via open or endovascular means) in the acute phases after injury
Key inclusion criteria (4 listed)
- All adult (age ≥ 18 years) trauma and acute care surgery patients treated with resuscitative AO (via open or endovascular means) in the acute phases after injury
- Transient or refractory hypotension (systolic blood pressure <90mmHg) with a positive abdominal focused abdominal sonography in trauma (FAST) scan, severe pelvic fracture(s), or neither with persistent hypotension without obvious source
- Chest x-ray without evidence of thoracic aortic injury
- Subject treatment includes internal aortic cross-clamp or would have likely benefited from an internal aortic cross-clamp
Key exclusion criteria (4 listed)
- Subject < 18 years of age
- Prisoner
- Evidence of cardiac, thoracic aortic, or great vessel injury identified in primary survey, FAST scan, and/or x-rays
- Any open/exsanguinating upper extremity wound
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 |
|---|---|---|
| utilization of AO in the acute resuscitation of trauma and acute care surgery patients in shock.AO to facilitate the acute resuscitation of trauma and acute care surgery patients in shock. | Procedure or surgery | – |
Primary outcome
Demographics
Time frame: 01 July 2015 through 31st December 2024
Age in years
Demographics- Gender
Time frame: 01 July 2015 through 31st December 2024
Male or Female
Demographics-Height
Time frame: 01 July 2015 through 31st December 2024
Height measured in Inches
Demographics- Weight
Time frame: 01 July 2015 through 31st December 2024
Weight measured in pounds
Injury Data
Time frame: 01 July 2015 through 31st December 2024
Mechanism classification - Penetrating, Blunt or Non-trauma Hemorrhage
Injury Mechanism Type
Time frame: 01 July 2015 through 31st December 2024
Gunshot wound, Motor vehicle accident, stab wound, fall
Body Region
Time frame: 01 July 2015 through 31st December 2024
Head/Neck, Chest, Abdomen, pelvis or Extremities
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- 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.
Conner McDaniel, M.D. principal investigator
Methodist Health System
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 Aortic Occlusion, 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Mar 2024. 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?
Results are not available in the source record.
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?
Demographics (time frame: 01 July 2015 through 31st December 2024). The study lists 7 primary outcomes in all. 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 28 Mar 2024.