Clinical trial NCT05263765: Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery
Official title: Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Aortic Occlusion
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Demographics
timeFrame: 01 July 2015 through 31st December 2024
measure: Demographics- Gender
timeFrame: 01 July 2015 through 31st December 2024
measure: Demographics-Height
timeFrame: 01 July 2015 through 31st December 2024
measure: Demographics- Weight
timeFrame: 01 July 2015 through 31st December 2024
measure: Injury Data
timeFrame: 01 July 2015 through 31st December 2024
measure: Injury Mechanism Type
timeFrame: 01 July 2015 through 31st December 2024
measure: Body Region
timeFrame: 01 July 2015 through 31st December 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Conner McDaniel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: